Relapsed/Refractory Multiple MyelomaPhase 2IZALCONCT05704049
A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase 2 study testing Isatuximab, Carfilzomib and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by Sanofi at 23 sites in 7 countries.
Trial summary
The main purpose of this study is to measure the efficacy (Myeloma response) of subcutaneous (SC) isatuximab treatment in combination with carfilzomib and dexamethasone in adult participants with RRMM having received 1 to 3 prior lines of therapy, and to characterize the PK of isatuximab in combination with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- Isatuximab, Carfilzomib and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 23 sitesin 7 countries
- Study dates
- 5 Apr 2023to 12 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a documented diagnosis of multiple myeloma (MM)
- Participants with measurable disease defined as at least one of the following:
- Serum M-protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or
- Urine M-protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or
- Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
- Participant with relapsed and/or refractory MM with at least 1 prior line of therapy and no more than 3 prior lines of therapy.
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- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either is not a female of childbearing potential (FCBP) or agrees to practice complete abstinence or use approved contraception methods.
- Male participants agree to practice true abstinence or agree to use approved contraception methods while receiving study treatment, during dose interruptions and at least 5 months following study treatment discontinuation, even if has undergone a successful vasectomy.
- Capable of giving signed informed consent.
Who cannot join
- Primary refractory MM defined as participants who have never achieved at least a minimal response (MR) with any treatment during the disease course
- Participants with prior anti-CD38 treatment if: a) administered <9 months before first isatuximab administration or randomization as applicable or, b) Intolerant to the anti-CD38 previously received
- Prior treatment with carfilzomib
- Known history of allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib), prior hypersensitivity to sucrose, histidine (as base and hydrochloride salt), polysorbate 80, or any of the components (active substance or excipient) of study treatment that are not amenable to premedication with steroids, or intolerance to arginine and Poloxamer 188 that would prohibit further treatment with these agents
- Uncontrolled or active infection with hepatitis A, B, and C virus; known acquired immunodeficiency syndrome (AIDS)-related illness; active primary amyloid light chain (AL) amyloidosis
- Any severe acute or chronic medical condition which could impair the ability of the participant to participate in the study or interfere with interpretation of study results (eg, systemic infection unless specific anti-infective therapy is employed) or participant unable to comply with the study procedures.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
23 sites in 7 countries.
23 sites in 7 countries
China7 sites
Investigational Site Number : 1560006
Changsha, 410013
Investigational Site Number : 1560002
Guangzhou, 510060
Investigational Site Number : 1560005
Nanchang, 330006
Investigational Site Number : 1560004
Shenyang, 110004
Investigational Site Number : 1560001
Tianjin, 300020
Investigational Site Number : 1560007
Tianjin, 300060
Investigational Site Number : 1560003
Wuhan, 430030
Czechia4 sites
Investigational Site Number : 2030002
Brno, 625 00
Investigational Site Number : 2030004
Olomouc, 779 00
Investigational Site Number : 2030003
Ostrava, 708 52
Investigational Site Number : 2030001
Prague, 128 08
Brazil3 sites
Hospital Mae de Deus Site Number : 0760002
Porto Alegre, Rio Grande do Sul, 90880-480
Clinica São Germano- Site Number : 0760003
São Paulo, 04537-080
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001
São Paulo, 05403-000
Portugal3 sites
Investigational Site Number : 6200001
Braga, 4710-243
Investigational Site Number : 6200004
Lisbon, 1400-038
Investigational Site Number : 6200005
Lisbon, 1649-035
Australia2 sites
Investigational Site Number : 0360001
Melbourne, Victoria, 3065
Investigational Site Number : 0360002
Wollongong, New South Wales, 2500
Greece2 sites
Investigational Site Number : 3000001
Athens, 106 76
Investigational Site Number : 3000002
Athens, 115 28
Japan2 sites
Investigational Site Number : 3920001
Kashiwa, Chiba, 277-8577
Investigational Site Number : 3920002
Okayama, 701-1192
About this study
Official title: A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)
The main purpose of this study is to measure the efficacy (Myeloma response) of subcutaneous (SC) isatuximab treatment in combination with carfilzomib and dexamethasone in adult participants with RRMM having received 1 to 3 prior lines of therapy, and to characterize the PK of isatuximab in combination with carfilzomib and dexamethasone after manual and On Body Delivery System (OBDS) administration. After confirmation of the feasibility of SC isatuximab by manual administration, patient will be randomized to 1 of the 2 delivery methods of SC isatuximab.
Read the detailed description
The duration of the study for a participant will include a period for screening of up to 28 days. A cycle duration is 28 days. Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue treatment, or any other reason, as well as the study treatment is commercially available and reimbursed in the participant's country, or is available from another source, whichever is first. The overall study duration will be of approximately 45 months.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- Isatuximab, Carfilzomib, Dexamethasone, Dexamethasone IV, Montelukast
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsatuximabDrug
Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous
CarfilzomibDrug
Also called Kyprolis
Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous
DexamethasoneDrug
Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral
Dexamethasone IVDrug
Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous
MontelukastDrug
Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral
AcetaminophenDrug
Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)
DiphenhydramineDrug
Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV
Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: manual administration | Experimental | Isatuximab will be administered manually for 8 minutes on Day 1 of Cycle 1 followed by 6 minutes from Day 8 of Cycle 1 and thereafter, in combination with carfilzomib and dexamethasone. Participants may receive other treatments as rescue medication or background medication. Receives: Drug: Isatuximab; Drug: Carfilzomib; Drug: Dexamethasone; Drug: Dexamethasone IV; Drug: Montelukast; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Methylprednisolone |
| Part 1 Cohort 2: manual administration | Experimental | Isatuximab will be administered manually for 6 minutes on Day 1 of Cycle 1 and thereafter, in combination with carfilzomib and dexamethasone. Participants may receive other treatments as rescue medication or background medication. Receives: Drug: Isatuximab; Drug: Carfilzomib; Drug: Dexamethasone; Drug: Dexamethasone IV; Drug: Montelukast; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Methylprednisolone |
| Part 2 Cohort 3 Randomized Cohort: OBDS to manual | Experimental | Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication. Receives: Drug: Isatuximab; Drug: Carfilzomib; Drug: Dexamethasone; Drug: Dexamethasone IV; Drug: Montelukast; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Methylprednisolone |
| Part 2 Cohort 3 Randomized Cohort: Manual to OBDS | Experimental | Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication. Receives: Drug: Isatuximab; Drug: Carfilzomib; Drug: Dexamethasone; Drug: Dexamethasone IV; Drug: Montelukast; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Methylprednisolone |
| Part 3 Cohort 4 Randomized Cohort: OBDS to manual | Experimental | Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication. Receives: Drug: Isatuximab; Drug: Carfilzomib; Drug: Dexamethasone; Drug: Dexamethasone IV; Drug: Montelukast; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Methylprednisolone |
| Part 3 Cohort 4: Randomized Cohort: manual to OBDS | Experimental | Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication. Receives: Drug: Isatuximab; Drug: Carfilzomib; Drug: Dexamethasone; Drug: Dexamethasone IV; Drug: Montelukast; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Methylprednisolone |
| Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants | Experimental | Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication. Receives: Drug: Isatuximab; Drug: Carfilzomib; Drug: Dexamethasone; Drug: Dexamethasone IV; Drug: Montelukast; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Methylprednisolone |
| Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants | Experimental | Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication. Receives: Drug: Isatuximab; Drug: Carfilzomib; Drug: Dexamethasone; Drug: Dexamethasone IV; Drug: Montelukast; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR) - Cohorts 1 to 3
ORR defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria assessed by Independent Review Committee (IRC).
Measured: 6 months after the Last Participant In (LPI) i.e., approximately 16 months
Maximum observed concentration (Cmax) over Cycle 1- Cohorts 4 to 5
Measured: Cycle 1 (28 days)
Cumulative area under the curve over the first 4 weeks (AUC4weeks) of isatuximab treatment- Cohorts 4 to 5
Measured: Cycle 1 (28 days)
Secondary outcomes (17)
Proportion of participants preferring OBDS over manual administration of isatuximab SC at Day 15 of Cycle 6
Patient preference for method of administration defined as the proportion of participants preferring OBDS over manual administration of isatuximab SC at Day 15 of Cycle 6 using the patient experience and satisfaction questionnaire version 2 (PESQ v2).
Measured: 6 months from LPI i.e., approximately 16 months
Incidence rate of infusion reactions (IRs)
Measured: From the signing of the informed consent to 30 days following the last administration of any study treatment i.e., up to approximately 45 months
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and changes in laboratory parameters
Measured: From the signing of the informed consent to 30 days following the last administration of any study treatment i.e., up to approximately 45 months
Incidence rate of injection site reactions (ISRs)
Measured: 18 months after LPI i.e., approximately 28 months
PK concentration: trough plasma concentration (Ctrough)
Blood samples will be collected for measurement of isatuximab concentrations.
Measured: Cycle 2 Day 1 and Cycle 6 Day 1 (1 Cycle = 28 days)
Overall response rate (ORR)
Proportion of participants with sCR, CR, VGPR, and PR according to the 2016 IMWG criteria assessed by investigator.
Measured: 6 months after the Last Participant In (LPI) i.e., approximately 16 months
Duration of response (DOR)
DOR defined as time from date of first IRC-determined response for participants achieving PR or better to first documentation of progressive disease (PD) determined by IRC or death, whichever occurred first, for Cohorts 1 to 3. For Cohorts 4-5, the time from date of first investigator determined response for participants achieving PR or better to first documentation of progressive disease (PD) determined by investigator or death, whichever occurred first.
Measured: 6 months after the Last Participant In (LPI) i.e., approximately 16 months
Time to first response (TT1R)
TT1R defined as time from first investigational medicinal product (IMP) administration or randomization to first IRC determined response (PR or better) that is subsequently confirmed, for Cohorts 1 to 3. For cohorts 4-5, the time from first IMP administration or randomization to first investigator determined response (PR or better) that is subsequently confirmed.
Measured: 6 months after the Last Participant In (LPI) i.e., approximately 16 months
Time to best response (TTBR)
TTBR defined as time from first IMP administration or randomization to first occurrence of IRC determined best response (PR or better) that is subsequently confirmed, for Cohorts 1 to 3. For cohorts 4-5, the time from first IMP administration or randomization to first occurrence of investigator determined best response (PR or better) that is subsequently confirmed.
Measured: 6 months after the Last Participant In (LPI) i.e., approximately 16 months
Progression free survival (PFS)
PFS defined as time from the date of first IMP administration or randomization to the date of first documentation of PD as determined by IRC for Cohorts 1 to 3 and by Investigator for all cohorts, or the date of death from any cause, whichever comes first.
Measured: 18 months after LPI i.e., approximately 28 months
Overall survival (OS)
OS defined as time from the date of first IMP administration or randomization to death from any cause.
Measured: 18 months after LPI i.e., approximately 28 months
Incidence of participants with anti-drug antibodies (ADA) against isatuximab
Measured: From Cycle 1 Day 1 to follow-up (90 days from last administration) i.e., approximately 13 months (1 Cycle = 28 days)
Patient Expectations Questionnaire at Baseline (PEQ-BL v2) with isatuximab administered subcutaneously
PEQ-BL v2 is a participant assessed questionnaire. It will be completed at baseline prior to study treatment administration or other study related procedures. This questionnaire has been designed to assess the expectations of the participants regarding both the treatment (side effects, worth taking) and the administration method (confidence, comfortability, pain, side effects, potential time-savings), as well as to understand previous treatment experience from the participant (experience with injection methods for oncology medication).
Measured: Baseline
Patient experience and satisfaction questionnaires (PESQ v2) with isatuximab administered subcutaneously
PESQ v2 is a participant assessed questionnaire. It has been designed to follow up on participant experience and satisfaction regarding the treatment (side effects, worth taking and overall satisfaction) and the administration method (confidence, comfortability, pain, side effects, potential time-savings and overall satisfaction). The PESQ v2 includes items to assess preference on subcutaneous injection method. This questionnaire has been developed using industry standard for instrument development and has been debriefed and adapted based on qualitative interviews with oncology patients. The more general treatment expectations instrument (v1) was further adapted and debriefed with patients to assess manual and OBDS subcutaneous delivery (v2). The PESQ v2 contains a total of 9 items. There are 6 items that are administered for the duration of treatment, and 3 preference items administered only after patient experience of both manual and OBDS.
Measured: 18 months after LPI i.e., approximately 28 months
Health state utility assessed using Health Resource Utilization and Productivity Questionnaire (HRUPQ)
Medical resource utilization and participant productivity will be collected from participants through a specific questionnaire developed by Sanofi for cohorts 1,2, 3, and 5. The data collected include number, nature (emergency or routine) and duration of hospitalizations, emergency room visits and outpatient medical encounters and employment history.
Measured: 18 months after LPI i.e., approximately 28 months
Health Related Quality of Life (HRQL)
HRQL is assessed for cohorts 1, 2, and 3 using the European Organization for Research and Treatment of Cancer (EORTC) myeloma module with 20 items (QLQ-MY20) and EORTC quality of life questionnaire with 30 questions (QLQ-C30); a total of 50 items. The EORTC QLQ-C30 provides a comprehensive assessment of the principal HRQL dimensions identified as relevant by cancer patients. The EORTC QLQ-MY20 is to be used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impact HRQL in participants with MM.
Measured: 18 months after LPI i.e., approximately 28 months
European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)
Health status is assessed for cohorts 1, 2, and 3, using the EQ-5D-5L, a standardized measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and VAS. The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The VAS records the respondent's self-rated health on a 20 cm vertical VAS with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents.
Measured: 18 months after LPI i.e., approximately 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start5 Apr 2023
- Primary completion22 Dec 2025
- Study completion12 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704049
- Sponsor's protocol ID
- ACT17453
- Other IDs
- U1111-1280-5090, 2023-508870-27, 2023
- Acronym
- IZALCO
- Status last verified
- Dec 2025
- First submitted
- 20 Jan 2023
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Parmar G, Capra M, Seguro F, Hungria V, Dimopoulos MA, Delimpasi S, Minarik J, Spicka I, Pour L, Marques H, Esteves G, Sunami K, Yuda J, Hajek R, Mihalyova J, Soufflet C, Yu D, Benlhassan K, Koch V, Comerford E, Cordero P, Suzan F, Quach H. Efficacy and safety of isatuximab subcutaneous plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma: results of the Phase 2 study IZALCO. Blood Cancer J. 2025 Dec 27;16(1):16. doi: 10.1038/s41408-025-01436-0.
PubMed 41455697
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)
- ClinicalTrials.gov ID
- NCT05704049
- Acronym / sponsor ID
- IZALCO / ACT17453
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 12 May 2028 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to measure the efficacy (Myeloma response) of subcutaneous (SC) isatuximab treatment in combination with carfilzomib and dexamethasone in adult participants with RRMM having received 1 to 3 prior lines of therapy, and to characterize the PK of isatuximab in combination with carfilzomib and dexamethasone after manual and On Body Delivery System (OBDS) administration. After confirmation of the feasibility of SC isatuximab by manual administration, patient will be randomized to 1 of the 2 delivery methods of SC isatuximab.
Detailed description
The duration of the study for a participant will include a period for screening of up to 28 days. A cycle duration is 28 days. Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue treatment, or any other reason, as well as the study treatment is commercially available and reimbursed in the participant's country, or is available from another source, whichever is first. The overall study duration will be of approximately 45 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: manual administration | Experimental | Drug: Isatuximab, Drug: Carfilzomib, Drug: Dexamethasone, Drug: Dexamethasone IV, Drug: Montelukast, Drug: Acetaminophen, Drug: Diphenhydramine, Drug: MethylprednisoloneIsatuximab will be administered manually for 8 minutes on Day 1 of Cycle 1 followed by 6 minutes from Day 8 of Cycle 1 and thereafter, in combination with carfilzomib and dexamethasone. Participants may receive other treatments as rescue medication or background medication. |
| Part 1 Cohort 2: manual administration | Experimental | Drug: Isatuximab, Drug: Carfilzomib, Drug: Dexamethasone, Drug: Dexamethasone IV, Drug: Montelukast, Drug: Acetaminophen, Drug: Diphenhydramine, Drug: MethylprednisoloneIsatuximab will be administered manually for 6 minutes on Day 1 of Cycle 1 and thereafter, in combination with carfilzomib and dexamethasone. Participants may receive other treatments as rescue medication or background medication. |
| Part 2 Cohort 3 Randomized Cohort: OBDS to manual | Experimental | Drug: Isatuximab, Drug: Carfilzomib, Drug: Dexamethasone, Drug: Dexamethasone IV, Drug: Montelukast, Drug: Acetaminophen, Drug: Diphenhydramine, Drug: MethylprednisoloneIsatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication. |
| Part 2 Cohort 3 Randomized Cohort: Manual to OBDS | Experimental | Drug: Isatuximab, Drug: Carfilzomib, Drug: Dexamethasone, Drug: Dexamethasone IV, Drug: Montelukast, Drug: Acetaminophen, Drug: Diphenhydramine, Drug: MethylprednisoloneIsatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication. |
| Part 3 Cohort 4 Randomized Cohort: OBDS to manual | Experimental | Drug: Isatuximab, Drug: Carfilzomib, Drug: Dexamethasone, Drug: Dexamethasone IV, Drug: Montelukast, Drug: Acetaminophen, Drug: Diphenhydramine, Drug: MethylprednisoloneIsatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication. |
| Part 3 Cohort 4: Randomized Cohort: manual to OBDS | Experimental | Drug: Isatuximab, Drug: Carfilzomib, Drug: Dexamethasone, Drug: Dexamethasone IV, Drug: Montelukast, Drug: Acetaminophen, Drug: Diphenhydramine, Drug: MethylprednisoloneIsatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication. |
| Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants | Experimental | Drug: Isatuximab, Drug: Carfilzomib, Drug: Dexamethasone, Drug: Dexamethasone IV, Drug: Montelukast, Drug: Acetaminophen, Drug: Diphenhydramine, Drug: MethylprednisoloneIsatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication. |
| Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants | Experimental | Drug: Isatuximab, Drug: Carfilzomib, Drug: Dexamethasone, Drug: Dexamethasone IV, Drug: Montelukast, Drug: Acetaminophen, Drug: Diphenhydramine, Drug: MethylprednisoloneIsatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must have a documented diagnosis of multiple myeloma (MM)
- Participants with measurable disease defined as at least one of the following:
- Participant with relapsed and/or refractory MM with at least 1 prior line of therapy and no more than 3 prior lines of therapy.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either is not a female of childbearing potential (FCBP) or agrees to practice complete abstinence or use approved contraception methods.
- Male participants agree to practice true abstinence or agree to use approved contraception methods while receiving study treatment, during dose interruptions and at least 5 months following study treatment discontinuation, even if has undergone a successful vasectomy.
Key exclusion criteria (7 listed)
- Primary refractory MM defined as participants who have never achieved at least a minimal response (MR) with any treatment during the disease course
- Participants with prior anti-CD38 treatment if: a) administered <9 months before first isatuximab administration or randomization as applicable or, b) Intolerant to the anti-CD38 previously received
- Prior treatment with carfilzomib
- Known history of allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib), prior hypersensitivity to sucrose, histidine (as base and hydrochloride salt), polysorbate 80, or any of the components (active substance or excipient) of study treatment that are not amenable to premedication with steroids, or intolerance to arginine and Poloxamer 188 that would prohibit further treatment with these agents
- Uncontrolled or active infection with hepatitis A, B, and C virus; known acquired immunodeficiency syndrome (AIDS)-related illness; active primary amyloid light chain (AL) amyloidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsatuximabInvestigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous | Drug | Cohort 1: manual administration, Part 1 Cohort 2: manual administration, Part 2 Cohort 3 Randomized Cohort: Manual to OBDS, Part 2 Cohort 3 Randomized Cohort: OBDS to manual, Part 3 Cohort 4 Randomized Cohort: OBDS to manual, Part 3 Cohort 4: Randomized Cohort: manual to OBDS, Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants, Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants |
| CarfilzomibAlso: KyprolisInvestigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous | Drug | Cohort 1: manual administration, Part 1 Cohort 2: manual administration, Part 2 Cohort 3 Randomized Cohort: Manual to OBDS, Part 2 Cohort 3 Randomized Cohort: OBDS to manual, Part 3 Cohort 4 Randomized Cohort: OBDS to manual, Part 3 Cohort 4: Randomized Cohort: manual to OBDS, Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants, Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants |
| DexamethasoneInvestigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral | Drug | Cohort 1: manual administration, Part 1 Cohort 2: manual administration, Part 2 Cohort 3 Randomized Cohort: Manual to OBDS, Part 2 Cohort 3 Randomized Cohort: OBDS to manual, Part 3 Cohort 4 Randomized Cohort: OBDS to manual, Part 3 Cohort 4: Randomized Cohort: manual to OBDS, Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants, Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants |
| Dexamethasone IVInvestigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous | Drug | Cohort 1: manual administration, Part 1 Cohort 2: manual administration, Part 2 Cohort 3 Randomized Cohort: Manual to OBDS, Part 2 Cohort 3 Randomized Cohort: OBDS to manual, Part 3 Cohort 4 Randomized Cohort: OBDS to manual, Part 3 Cohort 4: Randomized Cohort: manual to OBDS, Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants, Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants |
| MontelukastBackground Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral | Drug | Cohort 1: manual administration, Part 1 Cohort 2: manual administration, Part 2 Cohort 3 Randomized Cohort: Manual to OBDS, Part 2 Cohort 3 Randomized Cohort: OBDS to manual, Part 3 Cohort 4 Randomized Cohort: OBDS to manual, Part 3 Cohort 4: Randomized Cohort: manual to OBDS, Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants, Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants |
| AcetaminophenBackground Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV) | Drug | Cohort 1: manual administration, Part 1 Cohort 2: manual administration, Part 2 Cohort 3 Randomized Cohort: Manual to OBDS, Part 2 Cohort 3 Randomized Cohort: OBDS to manual, Part 3 Cohort 4 Randomized Cohort: OBDS to manual, Part 3 Cohort 4: Randomized Cohort: manual to OBDS, Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants, Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants |
| DiphenhydramineBackground Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV | Drug | Cohort 1: manual administration, Part 1 Cohort 2: manual administration, Part 2 Cohort 3 Randomized Cohort: Manual to OBDS, Part 2 Cohort 3 Randomized Cohort: OBDS to manual, Part 3 Cohort 4 Randomized Cohort: OBDS to manual, Part 3 Cohort 4: Randomized Cohort: manual to OBDS, Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants, Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants |
| MethylprednisoloneBackground Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV | Drug | Cohort 1: manual administration, Part 1 Cohort 2: manual administration, Part 2 Cohort 3 Randomized Cohort: Manual to OBDS, Part 2 Cohort 3 Randomized Cohort: OBDS to manual, Part 3 Cohort 4 Randomized Cohort: OBDS to manual, Part 3 Cohort 4: Randomized Cohort: manual to OBDS, Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants, Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants |
Primary outcome
Overall response rate (ORR) - Cohorts 1 to 3
Time frame: 6 months after the Last Participant In (LPI) i.e., approximately 16 months
ORR defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria assessed by Independent Review Committee (IRC).
Maximum observed concentration (Cmax) over Cycle 1- Cohorts 4 to 5
Time frame: Cycle 1 (28 days)
Cumulative area under the curve over the first 4 weeks (AUC4weeks) of isatuximab treatment- Cohorts 4 to 5
Time frame: Cycle 1 (28 days)
17 secondary outcomes
Proportion of participants preferring OBDS over manual administration of isatuximab SC at Day 15 of Cycle 6
Time frame: 6 months from LPI i.e., approximately 16 months
Incidence rate of infusion reactions (IRs)
Time frame: From the signing of the informed consent to 30 days following the last administration of any study treatment i.e., up to approximately 45 months
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and changes in laboratory parameters
Time frame: From the signing of the informed consent to 30 days following the last administration of any study treatment i.e., up to approximately 45 months
Incidence rate of injection site reactions (ISRs)
Time frame: 18 months after LPI i.e., approximately 28 months
PK concentration: trough plasma concentration (Ctrough)
Time frame: Cycle 2 Day 1 and Cycle 6 Day 1 (1 Cycle = 28 days)
Overall response rate (ORR)
Time frame: 6 months after the Last Participant In (LPI) i.e., approximately 16 months
Duration of response (DOR)
Time frame: 6 months after the Last Participant In (LPI) i.e., approximately 16 months
Time to first response (TT1R)
Time frame: 6 months after the Last Participant In (LPI) i.e., approximately 16 months
Time to best response (TTBR)
Time frame: 6 months after the Last Participant In (LPI) i.e., approximately 16 months
Progression free survival (PFS)
Time frame: 18 months after LPI i.e., approximately 28 months
Overall survival (OS)
Time frame: 18 months after LPI i.e., approximately 28 months
Incidence of participants with anti-drug antibodies (ADA) against isatuximab
Time frame: From Cycle 1 Day 1 to follow-up (90 days from last administration) i.e., approximately 13 months (1 Cycle = 28 days)
Patient Expectations Questionnaire at Baseline (PEQ-BL v2) with isatuximab administered subcutaneously
Time frame: Baseline
Patient experience and satisfaction questionnaires (PESQ v2) with isatuximab administered subcutaneously
Time frame: 18 months after LPI i.e., approximately 28 months
Health state utility assessed using Health Resource Utilization and Productivity Questionnaire (HRUPQ)
Time frame: 18 months after LPI i.e., approximately 28 months
Health Related Quality of Life (HRQL)
Time frame: 18 months after LPI i.e., approximately 28 months
European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)
Time frame: 18 months after LPI i.e., approximately 28 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Derived from this study: PubMed 41455697Parmar G, Capra M, Seguro F, Hungria V, Dimopoulos MA, Delimpasi S, Minarik J, Spicka I, Pour L, Marques H, Esteves G, Sunami K, Yuda J, Hajek R, Mihalyova J, Soufflet C, Yu D, Benlhassan K, Koch V, Comerford E, Cordero P, Suzan F, Quach H. Efficacy and safety of isatuximab subcutaneous plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma: results of the Phase 2 study IZALCO. Blood Cancer J. 2025 Dec 27;16(1):16. doi: 10.1038/s41408-025-01436-0.
- ACT17453 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
23 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isatuximab, Carfilzomib and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by Sanofi at 23 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China, Czechia, Brazil, Portugal, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) - Cohorts 1 to 3 (time frame: 6 months after the Last Participant In (LPI) i.e., approximately 16 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05704049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.