Plasma Cell MyelomaPhase 1NCT02513186

Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation

A Phase 1 study testing lenalidomide, bortezomib and cyclophosphamide in people with Plasma Cell Myeloma, run by Sanofi at 12 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary Objectives: VCDI cohort: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR650984 isatuximab when administered in combination with bortezomib (Velcade®) , cyclophosphamide, and dexamethasone (VCDI) based on the dose-limiting toxicity(ies) (DLTs) observed in patients with newly… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Plasma Cell Myeloma
What is being tested?: lenalidomide, bortezomib and cyclophosphamide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 12 sitesin 4 countries
Study dates: 30 Sep 2015to 22 Jan 2024
Phase: Phase 1
Are there results?: None posted in the registry

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

Newly diagnosed patients with measurable multiple myeloma defined as at least one of the following:
Serum M protein ≥1 g/dL (≥10 g/L).
Urine M protein ≥200 mg/24 hours.
Serum free light chain (sFLC) assay: involved free light chain assay ≥10 mg/dL (≥100 mg/L) and an abnormal sFLC ratio (<0.26 or >1.65).
Patients with ultra-high risk smoldering multiple myeloma fulfilling the International Myeloma Working Group criteria are eligible.
Patient is not eligible for transplant.
Patient with no intent for immediate transplant as per investigator's decision are also eligible for VRDI Part B cohort only.

Who cannot join

Eastern Cooperative Oncology Group performance status >2.
Poor bone marrow reserve.
Poor organ function.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

12 sites in 4 countries.

Country

City, postcode or hospital

12 sites in 4 countries

Spain4 sites

Investigational Site Number : 724003
Madrid, 28041
Investigational Site Number : 724001
Pamplona, Navarre, 31008
Investigational Site Number : 724002
Salamanca, 37007
Investigational Site Number : 724004
Santander, Cantabria, 39008

Other trials in Spain

France3 sites

Investigational Site Number : 250002
Nantes, 44093
Investigational Site Number : 250003
Pierre-Bénite, 69495
Investigational Site Number : 250001
Toulouse, 31059

Other trials in France

Italy3 sites

Investigational Site Number : 380003
Milan, 20132
Investigational Site Number : 380002
Roma, 00161
Investigational Site Number : 380001
Torino, 10126

Other trials in Italy

Germany2 sites

Investigational Site Number : 276003
Berlin, 12200
Investigational Site Number : 276002
Leipzig, 04103

Other trials in Germany

About this study

Official title: A Dose Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of SAR650984 (Isatuximab) Administered Intravenously in Combination With Bortezomib - Based Regimens in Adult Patients With Newly Diagnosed Multiple Myeloma Non Eligible for Transplantation or No Intent for Immediate Transplantation

Primary Objectives:

VCDI cohort:
To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR650984 isatuximab when administered in combination with bortezomib (Velcade®) , cyclophosphamide, and dexamethasone (VCDI) based on the dose-limiting toxicity(ies) (DLTs) observed in patients with newly diagnosed multiple myeloma non-eligible for transplantation
To evaluate safety and preliminary efficacy (overall response rate and complete response rate) of isatuximab administered at the selected dose in combination with bortezomib based regimin VCDI according to IMWG criteria.
VRDI Part A cohort and Part B cohort:
To evaluate the preliminary efficacy (complete response [CR] rate) of isatuximab administered at the selected dose in combination with bortezomib based regimen: VRDI, (bortezomib, lenalidomide, dexamethasone) according to IMWG criteria in adult patients with newly diagnosed MM non eligible for transplantation or no intent for immediate transplantation.

Secondary Objectives:

VCDI cohort:
To characterize the overall safety profile of SAR650984 in combination with VCD regimen, including cumulative toxicities.
To characterize the pharmacokinetic (PK) profile of SAR650984/isatuximab and each combination drug in VCDI regimen.
To evaluate the immunogenicity of SAR650984 in combination treatments.
To evaluate the preliminary efficacy of VCDI regimen in terms of duration of response and progression-free survival.
To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density.
VRDI Part A cohort and Part B cohort:
To characterize the overall safety profile of isatuximab in combination with VRD regimen.
To evaluate the infusion duration (only applicable for VRDI Part B cohort)
To characterize the PK profile of isatuximab and each combination drug in VRDI regimen.
To evaluate the immunogenicity of isatuximab in combination treatments.
To evaluate the preliminary efficacy of VRDI regimen in terms of ORR, DOR, and PFS.
To evaluate the impact of M protein measurement without isatuximab interference (via the SEBIA HYDRASHIFT 2/4 isatuximab IFE test) on CR and BOR assessment.
To assess the relationship between clinical effects (AE and/or tumor response) and CD38 receptor density (only applicable for VRDI Part A cohort).
To assess MRD negativity rate in patients achieving a CR or VGPR and explore correlation with clinical outcome.

Read the detailed description

The duration of the study for an individual patient will include:

A period to assess eligibility (screening or baseline period) of up to 3 weeks for VCDI cohort, up to 28 days for VRDI cohort;
for patients in the VCDI cohort: a treatment period including up to 12 induction treatment cycles (50-week duration).
for patients in the VRDI cohort: a treatment period including up to 4 induction cycles (24 week duration).
Following induction, both cohorts have maintenance periods consisting of 4 week cycles until progression, unacceptable AE, or patient willingness to discontinue and an end-of-treatment visit at least 30 days following the last administration of treatment.
Patients that discontinue therapy for reasons other than progression will have follow-up visits until progression or until the patient receives another anticancer therapy, whichever is earlier.

Conditions: Plasma Cell Myeloma
Being tested: lenalidomide, bortezomib, cyclophosphamide, dexamethasone, isatuximab SAR650984
Keywords: Anti-CD38 monoclonal antibody
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lenalidomideDrug
Also called Revlimid
Pharmaceutical form: tablet Route of administration: oral
bortezomibDrug
Also called Velcade
Pharmaceutical form: lyophilized powder for subcutaneous injection Route of administration: subcutaneous
cyclophosphamideDrug
Also called Endoxan
Pharmaceutical form: tablet Route of administration: oral
dexamethasoneDrug
Pharmaceutical form: tablet or solution for infusion Route of administration: oral or intravenous
isatuximab SAR650984Drug
Also called Sarclisa
Pharmaceutical form: solution for infusion Route of administration: intravenous

Study groups in NCT02513186
Study group	Role	What they receive
Isatuximab	Experimental	VCDI cohort: Isatuximab (escalating dose) + bortezomib + cyclophosphamide + dexamethasone (VCDI): Induction phase will be 50 weeks (12 cycles). The duration of a cycle will be 42 days (6 weeks) for Cycle 1 (C1) and 28 days (4 weeks) for subsequent cycles. The duration of a cycle of the maintenance phase will be 28 days (4 weeks). After C12, isatuximab will be administered at its initial assigned dose and dexamethasone once every 28 days. VRDI cohort parts A and B: Isatuximab + bortezomib + dexamethasone + lenalidomide (VRDI): Induction phase will be 24 weeks (4 cycles at 6 weeks/cycle). The duration of a cycle of the maintenance phase will be 28 days (4 weeks). Maintenance therapy may continue until disease progression, unacceptable AE or patient willingness to discontinue. VRDI Part A: Enrollment to begin after the VCDI cohort is completed. VRDI Part B: Enrollment to begin after the VRDI part A is completed. Receives: Drug: lenalidomide; Drug: bortezomib; Drug: cyclophosphamide; Drug: dexamethasone; Drug: isatuximab SAR650984

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of dose-limiting toxicities (DLTs) in VCDI cohort
Measured: Up to 6 weeks per treated patient
Overall response rate (VCDI)
Measured: Up to 34 weeks of treatment (induction phase)
Complete response rate (VCDI)
Measured: Up to 34 weeks of treatment (induction phase)
Complete response rate (VRDI)
Measured: Up to 104 weeks of treatment (induction and maintenance phase) in VRDI part A and part B cohorts

Secondary outcomes (10)

Number of patients with adverse events (AEs), clinically significant changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 grade scaling
Measured: VCDI: Up to approximately 106 weeks, VRDI Part A and Part B: Up to approximately 104 weeks
Overall response rate (VRDI)
Measured: Up to 104 weeks of treatment (induction and maintenance phase) in VRDI part A and part B cohorts
Infusion duration
Measured: VRDI Part B: Up to 104 weeks of treatment
Assessment of PK parameter: Partial area under the serum concentration time curve (AUC)
Measured: VCDI: Up to approximately 42 weeks, VRDI: Up to approximately 48 weeks
Assessment of PK parameter: Maximum observed concentration (Cmax)
Measured: VCDI: Up to approximately 42 weeks, VRDI: Up to approximately 48 weeks
Levels of human antidrug antibodies (ADA)
Measured: VCDI: Up to approximately 42 weeks, VRDI: Up to approximately 48 weeks
Duration of response - time
Measured: VCDI and VRDI: Until treatment discontinuation by the last patient
Progression-free survival for VCDI
Measured: VCDI: 30 months after LPI
Progression-free survival for VRDI
Measured: VRDI Part A and Part B: 24 months after LPI
MRD negativity rate
Measured: Up to 3 years of treatment (induction and maintenance phase) in VRDI part A and part B cohorts

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 201522 Jan 2024

First posted31 Jul 2015 (estimated)
Study start30 Sep 2015
Primary completion28 Jan 2022
Study completion22 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Plasma Cell 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02513186
Sponsor's protocol ID: TCD13983
Other IDs: U1111-1154-6102, 2014-001251-23, 2014
Status last verified: Jan 2024
First submitted: 16 Jul 2015
Last updated: 29 Jan 2024
Results posted: No
Data monitoring committee: 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

Ocio EM, Perrot A, Moreau P, Mateos MV, Bringhen S, Martinez-Lopez J, Karlin L, Oprea C, Li Y, Kodas E, San-Miguel J. Plain language summary of a study on 30-minute intravenous infusion of isatuximab in people with newly diagnosed multiple myeloma. Future Oncol. 2026 May;22(11):1235-1246. doi: 10.1080/14796694.2026.2652723. Epub 2026 Apr 27.
PubMed 42041169
Ocio EM, Perrot A, Bories P, San-Miguel JF, Blau IW, Karlin L, Martinez-Lopez J, Wang SY, Bringhen S, Marcatti M, Mateos MV, Rodriguez-Otero P, Oliva S, Nogai A, Le Roux N, Dong L, Mace S, Gassiot M, Fitzmaurice T, Oprea C, Moreau P. Efficacy and safety of isatuximab plus bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma ineligible/with no immediate intent for autologous stem cell transplantation. Leukemia. 2023 Jul;37(7):1521-1529. doi: 10.1038/s41375-023-01936-7. Epub 2023 Jun 14.
PubMed 37316728

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Active, not recruitingPhase 3
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Active, not recruitingPhase 1/2
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All Plasma Cell Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of SAR650984 (Isatuximab) Administered Intravenously in Combination With Bortezomib - Based Regimens in Adult Patients With Newly Diagnosed Multiple Myeloma Non Eligible for Transplantation or No Intent for Immediate Transplantation
ClinicalTrials.gov ID: NCT02513186
Acronym / sponsor ID: TCD13983
Conditions: Plasma Cell Myeloma
Keywords: Anti-CD38 monoclonal antibody
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: 30 Sep 2015 (actual)
Primary completion: 28 Jan 2022 (actual)
Study completion: 22 Jan 2024 (actual)
First posted: 31 Jul 2015 (estimated)
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.

Primary Objectives:

VCDI cohort:
To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR650984 isatuximab when administered in combination with bortezomib (Velcade®) , cyclophosphamide, and dexamethasone (VCDI) based on the dose-limiting toxicity(ies) (DLTs) observed in patients with newly diagnosed multiple myeloma non-eligible for transplantation
To evaluate safety and preliminary efficacy (overall response rate and complete response rate) of isatuximab administered at the selected dose in combination with bortezomib based regimin VCDI according to IMWG criteria.
VRDI Part A cohort and Part B cohort:
To evaluate the preliminary efficacy (complete response [CR] rate) of isatuximab administered at the selected dose in combination with bortezomib based regimen: VRDI, (bortezomib, lenalidomide, dexamethasone) according to IMWG criteria in adult patients with newly diagnosed MM non eligible for transplantation or no intent for immediate transplantation.

Secondary Objectives:

VCDI cohort:
To characterize the overall safety profile of SAR650984 in combination with VCD regimen, including cumulative toxicities.
To characterize the pharmacokinetic (PK) profile of SAR650984/isatuximab and each combination drug in VCDI regimen.
To evaluate the immunogenicity of SAR650984 in combination treatments.
To evaluate the preliminary efficacy of VCDI regimen in terms of duration of response and progression-free survival.
To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density.
VRDI Part A cohort and Part B cohort:
To characterize the overall safety profile of isatuximab in combination with VRD regimen.
To evaluate the infusion duration (only applicable for VRDI Part B cohort)
To characterize the PK profile of isatuximab and each combination drug in VRDI regimen.
To evaluate the immunogenicity of isatuximab in combination treatments.
To evaluate the preliminary efficacy of VRDI regimen in terms of ORR, DOR, and PFS.
To evaluate the impact of M protein measurement without isatuximab interference (via the SEBIA HYDRASHIFT 2/4 isatuximab IFE test) on CR and BOR assessment.
To assess the relationship between clinical effects (AE and/or tumor response) and CD38 receptor density (only applicable for VRDI Part A cohort).
To assess MRD negativity rate in patients achieving a CR or VGPR and explore correlation with clinical outcome.

Detailed description

The duration of the study for an individual patient will include:

A period to assess eligibility (screening or baseline period) of up to 3 weeks for VCDI cohort, up to 28 days for VRDI cohort;
for patients in the VCDI cohort: a treatment period including up to 12 induction treatment cycles (50-week duration).
for patients in the VRDI cohort: a treatment period including up to 4 induction cycles (24 week duration).
Following induction, both cohorts have maintenance periods consisting of 4 week cycles until progression, unacceptable AE, or patient willingness to discontinue and an end-of-treatment visit at least 30 days following the last administration of treatment.
Patients that discontinue therapy for reasons other than progression will have follow-up visits until progression or until the patient receives another anticancer therapy, whichever is earlier.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Isatuximab	Experimental	Drug: lenalidomide, Drug: bortezomib, Drug: cyclophosphamide, Drug: dexamethasone, Drug: isatuximab SAR650984VCDI cohort: Isatuximab (escalating dose) + bortezomib + cyclophosphamide + dexamethasone (VCDI): Induction phase will be 50 weeks (12 cycles). The duration of a cycle will be 42 days (6 weeks) for Cycle 1 (C1) and 28 days (4 weeks) for subsequent cycles. The duration of a cycle of the maintenance phase will be 28 days (4 weeks). After C12, isatuximab will be administered at its initial assigned dose and dexamethasone once every 28 days. VRDI cohort parts A and B: Isatuximab + bortezomib + dexamethasone + lenalidomide (VRDI): Induction phase will be 24 weeks (4 cycles at 6 weeks/cycle). The duration of a cycle of the maintenance phase will be 28 days (4 weeks). Maintenance therapy may continue until disease progression, unacceptable AE or patient willingness to discontinue. VRDI Part A: Enrollment to begin after the VCDI cohort is completed. VRDI Part B: Enrollment to begin after the VRDI part A is completed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Newly diagnosed patients with measurable multiple myeloma defined as at least one of the following:
Patients with ultra-high risk smoldering multiple myeloma fulfilling the International Myeloma Working Group criteria are eligible.
Patient is not eligible for transplant.
Patient with no intent for immediate transplant as per investigator's decision are also eligible for VRDI Part B cohort only.

Key exclusion criteria (4 listed)

Eastern Cooperative Oncology Group performance status >2.
Poor bone marrow reserve.
Poor organ function.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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
lenalidomideAlso: RevlimidPharmaceutical form: tablet Route of administration: oral	Drug	Isatuximab
bortezomibAlso: VelcadePharmaceutical form: lyophilized powder for subcutaneous injection Route of administration: subcutaneous	Drug	Isatuximab
cyclophosphamideAlso: EndoxanPharmaceutical form: tablet Route of administration: oral	Drug	Isatuximab
dexamethasonePharmaceutical form: tablet or solution for infusion Route of administration: oral or intravenous	Drug	Isatuximab
isatuximab SAR650984Also: SarclisaPharmaceutical form: solution for infusion Route of administration: intravenous	Drug	Isatuximab

Primary outcome

Assessment of dose-limiting toxicities (DLTs) in VCDI cohort
Time frame: Up to 6 weeks per treated patient
Overall response rate (VCDI)
Time frame: Up to 34 weeks of treatment (induction phase)
Complete response rate (VCDI)
Time frame: Up to 34 weeks of treatment (induction phase)
Complete response rate (VRDI)
Time frame: Up to 104 weeks of treatment (induction and maintenance phase) in VRDI part A and part B cohorts

10 secondary outcomes

Number of patients with adverse events (AEs), clinically significant changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 grade scaling
Time frame: VCDI: Up to approximately 106 weeks, VRDI Part A and Part B: Up to approximately 104 weeks
Overall response rate (VRDI)
Time frame: Up to 104 weeks of treatment (induction and maintenance phase) in VRDI part A and part B cohorts
Infusion duration
Time frame: VRDI Part B: Up to 104 weeks of treatment
Assessment of PK parameter: Partial area under the serum concentration time curve (AUC)
Time frame: VCDI: Up to approximately 42 weeks, VRDI: Up to approximately 48 weeks
Assessment of PK parameter: Maximum observed concentration (Cmax)
Time frame: VCDI: Up to approximately 42 weeks, VRDI: Up to approximately 48 weeks
Levels of human antidrug antibodies (ADA)
Time frame: VCDI: Up to approximately 42 weeks, VRDI: Up to approximately 48 weeks
Duration of response - time
Time frame: VCDI and VRDI: Until treatment discontinuation by the last patient
Progression-free survival for VCDI
Time frame: VCDI: 30 months after LPI
Progression-free survival for VRDI
Time frame: VRDI Part A and Part B: 24 months after LPI
MRD negativity rate
Time frame: Up to 3 years of treatment (induction and maintenance phase) in VRDI part A and part B cohorts

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
Derived from this study: PubMed 42041169Ocio EM, Perrot A, Moreau P, Mateos MV, Bringhen S, Martinez-Lopez J, Karlin L, Oprea C, Li Y, Kodas E, San-Miguel J. Plain language summary of a study on 30-minute intravenous infusion of isatuximab in people with newly diagnosed multiple myeloma. Future Oncol. 2026 May;22(11):1235-1246. doi: 10.1080/14796694.2026.2652723. Epub 2026 Apr 27.
Derived from this study: PubMed 37316728Ocio EM, Perrot A, Bories P, San-Miguel JF, Blau IW, Karlin L, Martinez-Lopez J, Wang SY, Bringhen S, Marcatti M, Mateos MV, Rodriguez-Otero P, Oliva S, Nogai A, Le Roux N, Dong L, Mace S, Gassiot M, Fitzmaurice T, Oprea C, Moreau P. Efficacy and safety of isatuximab plus bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma ineligible/with no immediate intent for autologous stem cell transplantation. Leukemia. 2023 Jul;37(7):1521-1529. doi: 10.1038/s41375-023-01936-7. Epub 2023 Jun 14.
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

Related trials for Plasma Cell Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Active, not recruitingPhase 2
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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

12 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lenalidomide, bortezomib and cyclophosphamide in people with Plasma Cell Myeloma, run by Sanofi at 12 sites in 4 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Spain, France, Italy, Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assessment of dose-limiting toxicities (DLTs) in VCDI cohort (time frame: Up to 6 weeks per treated patient). The study lists 4 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 NCT02513186, which also lists 2 linked publications.

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 Jan 2024.