Multiple MyelomaPhase 2NCT04653246
Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM
A Phase 2 study testing Isatuximab, Lenalidomide and Bortezomib Injection in people with Multiple Myeloma and Newly Diagnosed Multiple Myeloma (NDMM), run by Jacob Laubach, MD at 1 site in United States.
Trial summary
This research is testing whether the investigational drug isatuximab is safe and effective when used in combination with standard agents for the treatment of newly diagnosed multiple myeloma. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Autologous Stem Cell Transplant
- What is being tested?
- Isatuximab, Lenalidomide and Bortezomib Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2021to 13 Jan 2029
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- 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performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care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 ≤ 75 years, with patients over the age of 70 requiring PI approval
- Measurable disease defined as at least one of the following:
- Serum M protein ≥ 0.5 g/dL (≥5 g/L)
- Urine M protein ≥ 200 mg/24 hours
Show all 18Show fewer
- 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)
- Screening Laboratory evaluations within the following parameters
- Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 109/L) (Growth factors cannot be used within 14 days before first drug administration)
- Platelet count ≥ 75,000 cells/dL (75 x 109/L) if < 50% BM nucleated cells are plasma cells, ≥ 30,000 cells/dL if ≥ 50% of BM nucleated cells are plasma cells. (without transfusions required during the 3 days prior to the screening hematologic test)
- Total Bilirubin ≤ 2.0 X upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
- AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN
- Calculated creatinine clearance ≥ 30 mL/min
- Hemoglobin ≤ 8 g/dL
- ECOG performance status ≤ 2 (Appendix A)
- Participant agrees to be registered into the mandatory Revassist REMS® program, and be willing and able to comply with the requirements of the RevAssist REMS® program.
- 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 multiple myeloma
- Diagnosed or treated for another malignancy within 3 years prior to enrollment, 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 the past 6 months.
Show all 20Show fewer
- Prior major surgical procedure or radiation therapy within 4 weeks of initiation of therapy (this does not include limited course of radiation used for management of bone pain within 7 days of initiation of therapy).
- Daily requirement for corticosteroids (equivalent to > 10 mg/day prednisone for more than 7 days (except for inhalation corticosteroids).
- Concurrent symptomatic amyloidosis or plasma cell leukemia
- 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 therapy.
- 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. Females of childbearing potential (FCBP) unwilling to prevent pregnancy by the use of 2 reliable methods of contraception for ≥4 weeks before the start of study treatment, during treatment (including dose interruptions), and up to 3 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 1st month of treatment and then prior each treatment cycle administration or every 2 weeks in case or irregular menstrual cycles up to 3 months following the last dose of study treatment.
- Male participants who disagree to practice true abstinence or disagree to use a condom during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions and at least 3 months following study treatment discontinuation, even if 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 (ie, 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 (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Receiving any other investigational 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
- Hypersensitivity to steroids or H2 blockers that would prohibit further treatment with these agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Phase 2, Multi-Center, 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 research is testing whether the investigational drug isatuximab is safe and effective when used in combination with standard agents for the treatment of newly diagnosed multiple myeloma.
Read the detailed description
This is a multi-center, single-arm, open-label, Phase 2 study in patients with newly diagnosed multiple myeloma (NDMM) eligible for high dose therapy (HDT) and autologous stem cell transplant (ASCT).
In this research study, investigators are evaluating whether isatuximab is safe and effective in participants with newly diagnosed multiple myeloma when given in combination with lenalidomide, bortezomib, and dexamethsone.
- This research study involves administration of a four-drug chemotherapy regimen that combines the Investigational drug isatuximab with a standard chemotherapy regimen comprised of lenalidomide, bortezomib, and dexamethasone.
- This 4-drug regimen is not considered standard of the treatment of newly diagnosed multiple myeloma.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has approved lenalidomide, bortezomib, and dexamethasone as treatment options for this disease but the combination of these agents with isatuximab hasn't been approved.
- Conditions
- Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Autologous Stem Cell Transplant
- Being tested
- Isatuximab, Lenalidomide, Bortezomib Injection, Dexamethasone
- Keywords
- Multiple Myeloma, Newly diagnosed multiple myeloma (NDMM), Autologous stem cell transplant (ASCT)., High dose therapy (HDT)
- 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
Also called Sarclisa
Via IV at predetermined dosage and predetermined days during each cycle
LenalidomideDrug
Also called Revlimid
Oral, predetermined dosage and predetermined days during each cycle
Bortezomib InjectionDrug
SQ Oral, predetermined dosage and predetermined days during each cycle
DexamethasoneDrug
IV or Oral predetermined dosage and predetermined days during each cycle
| Study group | Role | What they receive |
|---|---|---|
| Isa-RVD | Experimental | The main study consists of 4 phases a) 28-day screening phase; b) an induction phase inclusive of two 42-day induction treatment cycles: Isatuximab (IV), Bortezomib (SQ). Lenalidomide (PO), Dexamethasone; c) Followed by stem cell mobilization (at the discretion of the Principal Investigator [PI]);d) Participants will proceed with either autologous stem cell transplant or two additional induction cycles.
- Induction will be followed by a maintenance phase that continues until disease progression. Receives: Drug: Isatuximab; Drug: Lenalidomide; Drug: Bortezomib Injection; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Very Good Partial Response (VGPR)
proportion of patients who have achieved VGPR or better, according to International Myeloma Working Group (IMWG) criteria (Kumar 2016), by the end of two cycles of induction treatment
Measured: 84 days
Secondary outcomes (6)
Time to Progression
Progression-free probabilities over time will be estimated using the Kaplan-Meier method (Kaplan, 1958), presenting an estimate of median time to progression (TTP) with 95% confidence intervals (CIs). Time to progression is defined as time from registration to progression, censored at date last known to be progression-free for those who have not progressed and censored at time of death for those who died.
Measured: time from registration to progression, censored at date last known to be progression-free for those who have not progressed and censored at time of death up to 42 months
Progression Free Survival
- Progression-free survival (PFS) will be analyzed similarly to time to progression: Progression-free probabilities over time will be estimated using the Kaplan-Meier method (Kaplan, 1958), presenting an estimate of median Time to progression (TTP) with 95% confidence intervals (CIs Time from registration to disease progression or death from any cause, censored at date last known to be progression-free for those who have not progressed or died
Measured: time from registration to disease progression or death from any cause, censored at date last known to be progression-free for those who have not progressed or died up to 42 months
Duration of Response
Duration of Response will be analyzed similarly to time to progression: Progression-free probabilities over time will be estimated using the Kaplan-Meier method (Kaplan, 1958), presenting an estimate of median time to progression (TTP) with 95% confidence intervals (CIs Time from first response after treatment to the date of disease progression or death from any cause, or date last known progression-free and alive for those who have not progressed or died.
Measured: Time from first response after treatment to the date of disease progression or death from any cause, or date last known progression-free and alive for those who have not progressed or died up to 42 months
Overall Survival
Overall Survival will be analyzed similarly to time to progression: Progression-free probabilities over time will be estimated using the Kaplan-Meier method (Kaplan, 1958), presenting an estimate of median time to progression (TTP) with 95% confidence intervals (CIs
Overall survival: time from registration to death from any cause or date last known alive for those who have not died
Measured: Overall survival: time from registration to death from any cause or date last known alive for those who have not died up to 42 months
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0
Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) v5.0
Measured: Induction to up to 3.5 years
stringent Complete Response (sCR)
proportion of patients who have achieved sCR, according to IMWG criteria, by the end of two cycles of induction treatment. Response will be evaluated using a Simon optimal two-stage design.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start13 Jul 2021
- Primary completion15 Dec 2025
- Study completion13 Jan 2029 (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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacob Laubach, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, Jacob Laubach, MD, Dana-Farber Cancer Institute
- Investigators
- Jacob C Laubach, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653246
- Sponsor's protocol ID
- 20-207
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2020
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multi-Center, 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
- NCT04653246
- Acronym / sponsor ID
- 20-207
- Conditions
- Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Autologous Stem Cell Transplant
- Keywords
- Multiple Myeloma, Newly diagnosed multiple myeloma (NDMM), Autologous stem cell transplant (ASCT)., High dose therapy (HDT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Jacob Laubach, MDUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 13 Jan 2029 (estimated)
- First posted
- 4 Dec 2020 (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 research is testing whether the investigational drug isatuximab is safe and effective when used in combination with standard agents for the treatment of newly diagnosed multiple myeloma.
Detailed description
This is a multi-center, single-arm, open-label, Phase 2 study in patients with newly diagnosed multiple myeloma (NDMM) eligible for high dose therapy (HDT) and autologous stem cell transplant (ASCT).
In this research study, investigators are evaluating whether isatuximab is safe and effective in participants with newly diagnosed multiple myeloma when given in combination with lenalidomide, bortezomib, and dexamethsone.
- This research study involves administration of a four-drug chemotherapy regimen that combines the Investigational drug isatuximab with a standard chemotherapy regimen comprised of lenalidomide, bortezomib, and dexamethasone.
- This 4-drug regimen is not considered standard of the treatment of newly diagnosed multiple myeloma.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has approved lenalidomide, bortezomib, and dexamethasone as treatment options for this disease but the combination of these agents with isatuximab hasn't been approved.
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: Lenalidomide, Drug: Bortezomib Injection, Drug: DexamethasoneThe main study consists of 4 phases a) 28-day screening phase; b) an induction phase inclusive of two 42-day induction treatment cycles: Isatuximab (IV), Bortezomib (SQ). Lenalidomide (PO), Dexamethasone; c) Followed by stem cell mobilization (at the discretion of the Principal Investigator [PI]);d) Participants will proceed with either autologous stem cell transplant or two additional induction cycles. - Induction will be followed by a maintenance phase that continues until disease progression. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 ≤ 75 years, with patients over the age of 70 requiring PI approval
- Measurable disease defined as at least one of the following:
- Screening Laboratory evaluations within the following parameters
Key exclusion criteria (20 listed)
- Prior therapy for multiple myeloma
- Diagnosed or treated for another malignancy within 3 years prior to enrollment, 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 |
|---|---|---|
| IsatuximabAlso: SarclisaVia IV at predetermined dosage and predetermined days during each cycle | Drug | Isa-RVD |
| LenalidomideAlso: RevlimidOral, predetermined dosage and predetermined days during each cycle | Drug | Isa-RVD |
| Bortezomib InjectionSQ Oral, predetermined dosage and predetermined days during each cycle | Drug | Isa-RVD |
| DexamethasoneIV or Oral predetermined dosage and predetermined days during each cycle | Drug | Isa-RVD |
Primary outcome
Very Good Partial Response (VGPR)
Time frame: 84 days
proportion of patients who have achieved VGPR or better, according to International Myeloma Working Group (IMWG) criteria (Kumar 2016), by the end of two cycles of induction treatment
6 secondary outcomes
Time to Progression
Time frame: time from registration to progression, censored at date last known to be progression-free for those who have not progressed and censored at time of death up to 42 months
Progression Free Survival
Time frame: time from registration to disease progression or death from any cause, censored at date last known to be progression-free for those who have not progressed or died up to 42 months
Duration of Response
Time frame: Time from first response after treatment to the date of disease progression or death from any cause, or date last known progression-free and alive for those who have not progressed or died up to 42 months
Overall Survival
Time frame: Overall survival: time from registration to death from any cause or date last known alive for those who have not died up to 42 months
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0
Time frame: Induction to up to 3.5 years
stringent Complete Response (sCR)
Time frame: 84 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 30 Apr 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Multiple 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)
Multiple Myeloma
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
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Jacob C Laubach, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isatuximab, Lenalidomide and Bortezomib Injection in people with Multiple Myeloma and Newly Diagnosed Multiple Myeloma (NDMM), run by Jacob Laubach, MD at 1 site in United States.
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 20 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Very Good Partial Response (VGPR) (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 30 Apr 2026.