Multiple MyelomaPhase 2Isa-RVDNCT05123131
Isa-RVD Study in Patients With Newly Diagnosed Multiple Myeloma
A Phase 2 study testing Isatuximab, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by Cancer Trials Ireland at 5 sites in 2 countries.
Trial summary
This study aims to evaluate the stringent Complete Response (sCR) rate by the end of two cycles of induction treatment, defined as the proportion of patients who have achieved sCR, according to International Myeloma Working Group (IMWG) criteria, by the end of two cycles of induction treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Isatuximab, Bortezomib and Lenalidomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Apr 2022to 15 Dec 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously diagnosed with MM based on standard IMWG criteria and currently requires treatment.
- Provided voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Age ≥18 years, ≤75 years, with patients over the age of 70 requiring CI approval.
- Measurable disease defined as at least one of the following:
- Serum M protein ≥0.5g/dL (≥5g/L)
- Urine M protein ≥200 mg/24 hours
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- Serum FLC assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
- Screening laboratory evaluations within the following parameters:
- ANC ≥ 1,000 cells/dL (1.0 x 10^9/L) (growth factors cannot be used within 14 days before first study treatment administration)
- Platelet count ≥75,000 cells/dL (75 x 10^9/L) if <50% BM nucleated cells are plasma cells, ≥30,000 cells/dL (30 x 10^9/L) if ≥50% of BM nucleated cells are plasma cells (without transfusions required during the 3 days prior to the screening haematologic test)
- Total bilirubin ≤2.0 X ULN (except patients with Gilbert Syndrome, who are eligible if total bilirubin <3.0 mg/dL)
- AST (SGOT) and ALT (SGPT) ≤3.0 x ULN
- Haemoglobin ≥8g/dL
- Calculated CrCl ≥30 mL/min
- ECOG performance status ≤ 2 (Appendix B).
- Participant agrees to be registered into the mandatory Risk Management Programme for Lenalidomide and be willing and able to comply with the requirements of this programme.
- Ability to understand and the willingness to sign a written informed consent document.
- Participant is considered eligible for ASCT by the treating physician.
Who cannot join
- Prior therapy for MM. Participants who received smouldering treatment qualify to participate as long as the prior treatment was not a CD38 therapy.
- Diagnosed or treated for another malignancy within 3 years prior to enrolment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy.
- Central nervous system involvement.
- Peripheral neuropathy ≥ Grade 3, or Grade 2 with pain on clinical examination during the screening period.
- Any medical or psychiatric illness that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study.
- Concurrent uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, Grade 3 thromboembolic event or myocardial infarction within 6 months prior to enrolment.
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- Prior major surgical procedure or radiation therapy within 4 weeks of initiation of study treatment (this does not include limited course of radiation used for management of bone pain within 7 days of initiation of study treatment)
- Daily requirement for corticosteroids (equivalent to >10 mg/day prednisone for more than 7 days (except for inhalation corticosteroids). Patients may receive corticosteroids for the management of their MM that should not exceed the equivalent of 160mg of dexamethasone in a 2-week period and should be stable for at least 7 days prior to the initiation of study treatment.
- Concurrent symptomatic amyloidosis or plasma cell leukaemia.
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
- Known active infection requiring parenteral or oral anti-infective treatment within 14 days of start of study treatment.
- Active hepatitis B or hepatitis C viral infection.
- Pregnant or breastfeeding female or female who intends to become pregnant during the participation in the study. FCBP unwilling to prevent pregnancy by the use of a highly effective method of contraception for ≥4 weeks before the start of study treatment, during treatment (including dose interruptions), and up to 5 months following the last dose of study treatment and/or who are unwilling or unable to be tested for pregnancy before study treatment initiation (2 negative tests), weekly during first month of treatment and then prior each treatment cycle administration or every 2 weeks in case or irregular menstrual cycles up to 5 months following the last dose of study treatment.
- Male participants who disagree to practice true abstinence or disagree to use highly effective contraception during sexual contact with a pregnant female or FCBP while participating in the study during dose interruptions and at least 5 months following study treatment discontinuation, even if he has undergone a successful vasectomy.
- Note 1: a FCBP is a female who: 1) has achieved menarche at some time point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months). Note 2: True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Receiving any other investigational agents.
- Hypersensitivity to steroids, or H2 blockers that would prohibit further treatment with these agents.
- Inability to tolerate thromboprophylaxis.
- Hypersensitivity (or contraindication) to dexamethasone, sucrose histidine (as base and hydrochloride salt), boron, mannitol, and polysorbate 80, or to any of the components of the study therapy.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Ireland4 sites
Beaumont Hospital
Dublin
Mater Misericordiae University Hospital
Dublin
St James's Hospital
Dublin
University Hospital Waterford
Waterford
About this study
Official title: Isa-RVD Study: Phase II, Multi-centre, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of the Combination Regimen Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
This study aims to evaluate the stringent Complete Response (sCR) rate by the end of two cycles of induction treatment, defined as the proportion of patients who have achieved sCR, according to International Myeloma Working Group (IMWG) criteria, by the end of two cycles of induction treatment.
- Conditions
- Multiple Myeloma
- Being tested
- Isatuximab, Bortezomib, Lenalidomide, Dexamethasone (IV)
- 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
Isatuximab (IV): 10 mg/kg on Days 1, 8, 15, 22, 29 in Cycle 1; from Cycle 2 onwards, it will be given on Days 1, 15, 29.
BortezomibDrug
Bortezomib (SQ): 1.3 mg/m² on Days 1, 4, 8, 11, 22, 25, 29, and 32.
LenalidomideDrug
Lenalidomide (PO): 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 to <60 mL/min) from Day 1 to Day 14 and from Day 22 to Day 35 of each cycle.
Dexamethasone (IV)Drug
Dexamethasone (IV on the days of Isatuximab and PO on other days): 20 mg/day on Days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, 23, 25, 26, 29, 30, 32, and 33. If patients are ≥75 years old, dexamethasone will be administered on Days 1, 4, 8, 11, 15, 16, 22, 25, 29 and 32.
| Study group | Role | What they receive |
|---|---|---|
| Isa-RVD | Experimental | Isatuximab (IV): 10 mg/kg on Days 1, 8, 15, 22, 29 in Cycle 1; from Cycle 2 onwards, it will be given on Days 1, 15, 29.
Bortezomib (SQ): 1.3 mg/m² on Days 1, 4, 8, 11, 22, 25, 29, and 32. Lenalidomide (PO): 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 to <60 mL/min) from Day 1 to Day 14 and from Day 22 to Day 35 of each cycle.
Dexamethasone (IV on the days of Isatuximab and PO on other days):
20 mg/day on Days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, 23, 25, 26, 29, 30, 32, and 33.
If patients are ≥75 years old, dexamethasone will be administered on Days 1, 4, 8, 11, 15, 16, 22, 25, 29 and 32. Receives: Drug: Isatuximab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the Very Good Partial Response (VGPR) or better rate by the end of two cycles of induction treatment
To evaluate the Very Good Partial Response (VGPR) or better rate by the end of two cycles of induction treatment, defined as the proportion of patients who have achieved VGPR, according to International Myeloma Working Group (IMWG) criteria, by the end of two cycles of induction treatment.
Measured: 84 days
Secondary outcomes (11)
To evaluate complete response (CR) and sCR rate following one year and two years of maintenance therapy.
Measured: 3.5 years
To evaluate overall response rate and rate of very good partial response (VGPR) or better following one year of maintenance therapy.
Measured: 3.5 years
To evaluate time to VGPR or better.
Measured: 3.5 years
To assess negative minimal residual disease (MRD) rate following ASCT and after 1 and 2 years of maintenance treatment.
Measured: 3.5 years
To evaluate clinical outcomes including time to progression (TTP).
Measured: 3.5 years
To evaluate clinical outcomes including progression-free survival (PFS).
Measured: 3.5 years
To evaluate clinical outcomes including overall survival (OS).
Measured: 3.5 years
To evaluate clinical outcomes including duration of response (DOR).
Measured: 3.5 years
To assess the safety of the Isa-RVD treatment regime based on reported adverse events and toxicity.
Measured: 3.5 years
To assess the tolerability of the Isa-RVD treatment regime based on reported adverse events and toxicity.
Measured: 3.5 years
To evaluate stem cell yield after mobilization.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Apr 2022
- Primary completion24 Jun 2025
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Collaborators
- Sanofi, Dana-Farber Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Prof Peter O'Gorman, Principal investigator, Mater Misericordiae University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123131
- Sponsor's protocol ID
- CTRIAL-IE 19-34
- Acronym
- Isa-RVD
- Status last verified
- Jul 2025
- First submitted
- 21 Sep 2021
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isa-RVD Study: Phase II, Multi-centre, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of the Combination Regimen Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05123131
- Acronym / sponsor ID
- Isa-RVD / CTRIAL-IE 19-34
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Collaborators
- Sanofi, Dana-Farber Cancer Institute
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 17 Nov 2021 (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.
This study aims to evaluate the stringent Complete Response (sCR) rate by the end of two cycles of induction treatment, defined as the proportion of patients who have achieved sCR, according to International Myeloma Working Group (IMWG) criteria, by the end of two cycles of induction treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isa-RVD | Experimental | Drug: Isatuximab, Drug: Bortezomib, Drug: Lenalidomide, Drug: Dexamethasone (IV)Isatuximab (IV): 10 mg/kg on Days 1, 8, 15, 22, 29 in Cycle 1; from Cycle 2 onwards, it will be given on Days 1, 15, 29. Bortezomib (SQ): 1.3 mg/m² on Days 1, 4, 8, 11, 22, 25, 29, and 32. Lenalidomide (PO): 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 to <60 mL/min) from Day 1 to Day 14 and from Day 22 to Day 35 of each cycle. Dexamethasone (IV on the days of Isatuximab and PO on other days): 20 mg/day on Days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, 23, 25, 26, 29, 30, 32, and 33. If patients are ≥75 years old, dexamethasone will be administered on Days 1, 4, 8, 11, 15, 16, 22, 25, 29 and 32. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Previously diagnosed with MM based on standard IMWG criteria and currently requires treatment.
- Provided voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Age ≥18 years, ≤75 years, with patients over the age of 70 requiring CI approval.
- Measurable disease defined as at least one of the following:
- Screening laboratory evaluations within the following parameters:
Key exclusion criteria (19 listed)
- Prior therapy for MM. Participants who received smouldering treatment qualify to participate as long as the prior treatment was not a CD38 therapy.
- Diagnosed or treated for another malignancy within 3 years prior to enrolment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy.
- Central nervous system involvement.
- Peripheral neuropathy ≥ Grade 3, or Grade 2 with pain on clinical examination during the screening period.
- Any medical or psychiatric illness that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study.
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 |
|---|---|---|
| IsatuximabIsatuximab (IV): 10 mg/kg on Days 1, 8, 15, 22, 29 in Cycle 1; from Cycle 2 onwards, it will be given on Days 1, 15, 29. | Drug | Isa-RVD |
| BortezomibBortezomib (SQ): 1.3 mg/m² on Days 1, 4, 8, 11, 22, 25, 29, and 32. | Drug | Isa-RVD |
| LenalidomideLenalidomide (PO): 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 to <60 mL/min) from Day 1 to Day 14 and from Day 22 to Day 35 of each cycle. | Drug | Isa-RVD |
| Dexamethasone (IV)Dexamethasone (IV on the days of Isatuximab and PO on other days): 20 mg/day on Days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, 23, 25, 26, 29, 30, 32, and 33. If patients are ≥75 years old, dexamethasone will be administered on Days 1, 4, 8, 11, 15, 16, 22, 25, 29 and 32. | Drug | Isa-RVD |
Primary outcome
To evaluate the Very Good Partial Response (VGPR) or better rate by the end of two cycles of induction treatment
Time frame: 84 days
To evaluate the Very Good Partial Response (VGPR) or better rate by the end of two cycles of induction treatment, defined as the proportion of patients who have achieved VGPR, according to International Myeloma Working Group (IMWG) criteria, by the end of two cycles of induction treatment.
11 secondary outcomes
To evaluate complete response (CR) and sCR rate following one year and two years of maintenance therapy.
Time frame: 3.5 years
To evaluate overall response rate and rate of very good partial response (VGPR) or better following one year of maintenance therapy.
Time frame: 3.5 years
To evaluate time to VGPR or better.
Time frame: 3.5 years
To assess negative minimal residual disease (MRD) rate following ASCT and after 1 and 2 years of maintenance treatment.
Time frame: 3.5 years
To evaluate clinical outcomes including time to progression (TTP).
Time frame: 3.5 years
To evaluate clinical outcomes including progression-free survival (PFS).
Time frame: 3.5 years
To evaluate clinical outcomes including overall survival (OS).
Time frame: 3.5 years
To evaluate clinical outcomes including duration of response (DOR).
Time frame: 3.5 years
To assess the safety of the Isa-RVD treatment regime based on reported adverse events and toxicity.
Time frame: 3.5 years
To assess the tolerability of the Isa-RVD treatment regime based on reported adverse events and toxicity.
Time frame: 3.5 years
To evaluate stem cell yield after mobilization.
Time frame: 90 days
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 8 Jul 2025.
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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.
Prof Peter O'Gorman principal investigator
Mater Misericordiae University Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isatuximab, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by Cancer Trials Ireland at 5 sites in 2 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 18 inclusion and 19 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 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ireland, Denmark. 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?
To evaluate the Very Good Partial Response (VGPR) or better rate by the end of two cycles of induction treatment (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2025.