Multiple MyelomaPhase 2KarMMa-2NCT03601078
An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma
A Phase 2 study testing bb2121, Lenalomide and Talquetamab in people with Multiple Myeloma, run by Celgene at 25 sites in 6 countries.
Trial summary
This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in participants with relapsed and refractory multiple myeloma (RRMM) (Cohort 1), in participants with RRMM who receive bridging therapy with talquetamab (Cohort 1b), in participants with multiple myeloma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- bb2121, Lenalomide and Talquetamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 25 sitesin 6 countries
- Study dates
- 13 Dec 2018to 15 Jan 2026
- Phase
- Phase 2
- 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
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
- For Cohorts 1 and 2 only, participant has measurable disease, defined as:
- M-protein (serum protein electrophoresis [sPEP] or urine protein electrophoresis [uPEP]): sPEP ≥ 0.5 g/dL or uPEP ≥ 200 mg/24 hours and/or
- Light chain MM without measurable disease in the serum or urine: Serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Subjects with one of the following cohort specific requirements:
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- Cohort 1 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens:
- Subject must have received at least 3 prior anti-myeloma treatment regimens. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen
- Subject must have undergone at least 2 consecutive cycles of treatment for each regimen, unless PD was the best response to the regimen
- Subject must have received prior treatment with a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody
- Subject has evidence of PD on or within 60 days of the most recent prior treatment regimen
- Subject achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
- Cohort 2 subjects with 1 prior anti-myeloma treatment regimen:
- Subject must have received only 1 prior anti-myeloma treatment regimen. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen
- Subject must have the following HR factors:
- Early relapse defined as:
- Cohort 2a: PD < 18 months since date of start of initial therapy. Initial therapy must contain induction, ASCT (single or tandem) and lenalidomide containing maintenance.
- Cohort 2b: PD < 18 months since date of start or initial therapy which must contain at minimum, a proteasome inhibitor, an immunomodulatory agent and dexamethasone Cohort 2c: Subject must have received minimum 3 cycles of induction therapy which must contain at minimum, a proteasome inhibitor, an immunomodulatory agent and dexamethasone. Subjects must have had ASCT (single or tandem AND < VGPR (excluding PD) at first assessment between 70 to 110 days after last ASCT, with initial therapy without consolidation and maintenance.
- Cohort 3 participants with newly diagnosed MM (NDMM) who received only induction and ASCT, without subsequent consolidation or maintenance Cohort 3
- Must have received 4 to 6 cycles of induction therapy which must contain at minimum, a proteasome inhibitor and an immunomodulatory agent and must have had single ASCT within 6 months prior to consent
- Must have achieved documented PR or VGPR at first post-ASCT assessment approximately 100 days after ASCT and this response must be maintained at screening
- Per Investigator's assessment, subject must be a candidate for single-agent lenalidomide maintenance
- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Subject must have recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subject used any investigational agents within 14 days prior to leukapheresis or, for Cohort 3, within 14 days prior to consent
- Subject received any of the following within the last 14 days prior to leukapheresis or, for Cohort 3, within 14 days prior to consent:
- Plasmapheresis
- Major surgery (as defined by the investigator)
- Radiation therapy other than local therapy for myeloma associated bone lesions
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- Use of any systemic anti-myeloma drug therapy
- Subject with known central nervous system involvement with myeloma
- Subject has clinical evidence of pulmonary leukostasis and disseminated intravascular coagulation
- History or presence of clinically relevant central nervous system (CNS) pathology
- Subject with active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or clinically significant amyloidosis
- Inadequate organ function Subject with a history of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months prior to starting study treatment
- Ongoing treatment with chronic immunosuppressants
- Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy
- Subject has received ASCT within 12 weeks prior to leukapheresis
- Subject has history of primary immunodeficiency
- Subject is positive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B or active hepatitis A or C
- Subject has uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment
- Subject with prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years
- Pregnant or lactating women
- Subject with known hypersensitivity to any component of bb2121 product, cyclophosphamide, fludarabine, and/or tocilizumab
- Prior history of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 6 months prior to consent (For Cohort 3)
- For Cohort 1b, previous treatment with any G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D) targeted therapy or T-cell engagers
- For Cohort 1b, known allergies, hypersensitivity, or intolerance to talquetamab or its excipients
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
United States18 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02117
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5450
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Levine Cancer Institute
Charlotte, North Carolina, 28204
University Of Texas Southwestern Medical Center
Dallas, Texas, 75390
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
MD Anderson Cancer Center The University of Texas
Houston, Texas, 77030
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Mt Sinai Medical Center - NY
New York, New York, 10029
Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York, 10032
University Of Nebraska
Omaha, Nebraska, 68198-7680
University Of California San Francisco Medical Center
San Francisco, California, 94143
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, 85259
Swedish Cancer Inst
Seattle, Washington, 98104
Washington University
St Louis, Missouri, 63110
Moffitt Cancer Center
Tampa, Florida, 33612
Germany2 sites
Local Institution - 506
Hamburg, 20246
Local Institution - 505
Würzburg, 97080
Spain2 sites
Clinica Universidad de Navarra
Pamplona, 31008
Local Institution - 704
Salamanca, 37007
United Kingdom1 site
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
About this study
Official title: A Phase 2, Multi-cohort, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With Clinical High-Risk Multiple Myeloma (KarMMa-2)
This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in participants with relapsed and refractory multiple myeloma (RRMM) (Cohort 1), in participants with RRMM who receive bridging therapy with talquetamab (Cohort 1b), in participants with multiple myeloma (MM) having progressed within 18 months of initial treatment with autologous stem cell transplantation (ASCT) (Cohort 2a) and without ASCT (Cohort 2b) or, in participants with inadequate response post ASCT during initial treatment (Cohort 2c) and the efficacy and safety of bb2121 used in combination with lenalidomide maintenance in participants with suboptimal response post ASCT (Cohort 3). Approximately 248 participants will be enrolled into one of three cohorts. Cohort 1 (including cohort 1b) will enroll approximately 126 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2a will enroll approximately 39 MM subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse. Cohort 2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not including ASCT and with early relapse. Cohort 2c will enroll approximately 30 MM subjects with inadequate response to ASCT during their initial anti-myeloma therapy. The cohorts will start in parallel and independently. Cohort 3 will enroll approximately 30 newly diagnosed multiple myeloma (NDMM) participants with suboptimal response to ASCT.
Read the detailed description
Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured for cohorts 1, 2a and 2b only. In Cohort 1b only, subjects will receive bridging therapy with 1 to 2 cycles of talquetamab, and initiate Lymphodepleting (LD) chemotherapy at least 14 days after the last dose of talquetamab.
- Conditions
- Multiple Myeloma
- Being tested
- bb2121, Lenalomide, Talquetamab
- Keywords
- Multiple Myeloma, bb2121, Relapsed and Refractory Multiple Myeloma, High Risk Multiple Myeloma, Phase 2, Multi-cohort, Open-label
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bb2121Biological
Also called BMS-986395
bb2121 consists of autologous T lymphocytes transduced with an anti-BCMA CAR lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR)
LenalomideDrug
Also called Revlimid®
Specified dose on specified days
TalquetamabDrug
Also called TALVEY
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: BB2121 in relapsed and refractory multiple myeloma participants | Experimental | bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy Receives: Biological: bb2121 |
| Cohort 1b: BB2121 with talquetamab in relapsed and refractory multiple myeloma participants | Experimental | Not described Receives: Biological: bb2121; Drug: Talquetamab |
| Cohort 2a: BB2121 in multiple myeloma with Autologous stem cell transplantation participants | Experimental | Not described Receives: Biological: bb2121 |
| Cohort 2b: BB2121 in multiple myeloma without Autologous stem cell transplantation participants | Experimental | Not described Receives: Biological: bb2121 |
| Cohort 2c: BB2121 in multiple myeloma participants with inadequate response post ASCT | Experimental | Not described Receives: Biological: bb2121 |
| Cohort 3: BB2121 with lenalidomide maintenance in newly diagnosed multiple myeloma | Experimental | Not described Receives: Biological: bb2121; Drug: Lenalomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)- Cohort 1
Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigator
Measured: Up to approximately 5 years (Participants will transition to the long term follow-up (LTFU) study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Complete response (CR) rate - Cohort 1b, 2a, 2b, 2c, and Cohort 3
Percentage of subjects who achieved CR or stringent CR according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigator
Measured: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Secondary outcomes (18)
Complete response (CR) rate - Cohort 1
Percentage of subjects who achieved CR or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigator
Measured: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Overall response rate (ORR) - Cohort 1b, 2a, b, c and Cohort 3
Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigator
Measured: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Very good partial response (VGPR) rate - Cohort 2c
Percentage of subjects who achieved VGPR or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigator
Measured: Up to approximately 5 years(Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Time to response (TTR)
Time from first bb2121 infusion to first documentation of response (PR or greater) [Cohorts 1 and 2]; time from first dose of lenalidomide pre-leukapheresis to first documentation of response [Cohort 3 only]
Measured: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Duration of response (DoR)
Time from first documentation of response (PR or greater) to first documentation of progressive disease (PD) or death from any cause, whichever occurs first
Measured: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Progression-free survival (PFS)
Time from first bb2121 infusion to first documentation of PD, or death due to any cause, whichever occurs first (Cohorts 1 and 2); time from first dose of lenalidomide pre-leukapheresis to first documentation of PD, or death due to any cause, whichever occurs first (Cohort 3 only)
Measured: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Time to progression (TTP)
Time from first bb2121 infusion to first documentation of PD (Cohorts 1 and 2); time from first dose of lenalidomide pre-leukapheresis to first documentation of PD (Cohort 3 only)
Measured: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Overall survival (OS)
Time from first bb2121 infusion to time of death due to any cause (Cohorts 1 and 2); time from first dose of lenalidomide pre-leukapheresis to time of death due to any cause (Cohort 3 only)
Measured: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Percentage of participants who received lenalidomide maintenance for the first 3 cycles following bb2121 infusion with at least 75% dose compliance - Cohort 3
Measured: Up to 3 months
Pharmacokinetics - Cmax
Maximum expansion of bb2121 chimeric antigen receptor (CAR) T cells
Measured: Minimum 5 years after bb2121 infusion
Pharmacokinetics - tmax
Time to peak of bb2121 CAR T cells
Measured: Minimum 5 years after bb2121 infusion
Pharmacokinetics - AUC
Area under the curve of CAR T cells
Measured: Minimum 5 years after bb2121 infusion
Pharmacokinetics - tlast
Time to last measurable CAR T cells
Measured: Minimum 5 years after bb2121 infusion
Pharmacokinetics - AUC0-28days
Area under the curve of CAR T cells from time zero to Day 28
Measured: Minimum 5 years after bb2121 infusion
Immunogenicity
Development of an anti-CAR antibody response
Measured: Minimum of 2 years after bb2121 infusion
Subject-reported outcomes as measured by European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC-QLQ-C30)
Questionnaire will be used as a measure of health-related quality of life
Measured: Minimum 5 years after bb2121 infusion
Subject-reported outcomes as measured by EuroQoL Group EQ-5D-5L Health Questionnaire
Is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal
Measured: Minimum 5 years after bb2121 infusion
Subject-reported outcomes as measured by EORTC-QLQ-MY20
Is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality
Measured: Minimum 5 years after bb2121 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start13 Dec 2018
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
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.
- More trials run by CelgeneThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601078
- Sponsor's protocol ID
- BB2121-MM-002
- Other IDs
- U1111-1216-4209, 2023-505183-10, 2023
- Acronym
- KarMMa-2
- Status last verified
- Mar 2026
- First submitted
- 17 Jul 2018
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-cohort, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With Clinical High-Risk Multiple Myeloma (KarMMa-2)
- ClinicalTrials.gov ID
- NCT03601078
- Acronym / sponsor ID
- KarMMa-2 / BB2121-MM-002
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, bb2121, Relapsed and Refractory Multiple Myeloma, High Risk Multiple Myeloma, Phase 2, Multi-cohort, Open-label
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 26 Jul 2018 (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 is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in participants with relapsed and refractory multiple myeloma (RRMM) (Cohort 1), in participants with RRMM who receive bridging therapy with talquetamab (Cohort 1b), in participants with multiple myeloma (MM) having progressed within 18 months of initial treatment with autologous stem cell transplantation (ASCT) (Cohort 2a) and without ASCT (Cohort 2b) or, in participants with inadequate response post ASCT during initial treatment (Cohort 2c) and the efficacy and safety of bb2121 used in combination with lenalidomide maintenance in participants with suboptimal response post ASCT (Cohort 3). Approximately 248 participants will be enrolled into one of three cohorts. Cohort 1 (including cohort 1b) will enroll approximately 126 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2a will enroll approximately 39 MM subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse. Cohort 2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not including ASCT and with early relapse. Cohort 2c will enroll approximately 30 MM subjects with inadequate response to ASCT during their initial anti-myeloma therapy. The cohorts will start in parallel and independently. Cohort 3 will enroll approximately 30 newly diagnosed multiple myeloma (NDMM) participants with suboptimal response to ASCT.
Detailed description
Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured for cohorts 1, 2a and 2b only. In Cohort 1b only, subjects will receive bridging therapy with 1 to 2 cycles of talquetamab, and initiate Lymphodepleting (LD) chemotherapy at least 14 days after the last dose of talquetamab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: BB2121 in relapsed and refractory multiple myeloma participants | Experimental | Biological: bb2121bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy |
| Cohort 1b: BB2121 with talquetamab in relapsed and refractory multiple myeloma participants | Experimental | Biological: bb2121, Drug: Talquetamab |
| Cohort 2a: BB2121 in multiple myeloma with Autologous stem cell transplantation participants | Experimental | Biological: bb2121 |
| Cohort 2b: BB2121 in multiple myeloma without Autologous stem cell transplantation participants | Experimental | Biological: bb2121 |
| Cohort 2c: BB2121 in multiple myeloma participants with inadequate response post ASCT | Experimental | Biological: bb2121 |
| Cohort 3: BB2121 with lenalidomide maintenance in newly diagnosed multiple myeloma | Experimental | Biological: bb2121, Drug: Lenalomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
- For Cohorts 1 and 2 only, participant has measurable disease, defined as:
- Subjects with one of the following cohort specific requirements:
- Cohort 2a: PD < 18 months since date of start of initial therapy. Initial therapy must contain induction, ASCT (single or tandem) and lenalidomide containing maintenance.
- Cohort 2b: PD < 18 months since date of start or initial therapy which must contain at minimum, a proteasome inhibitor, an immunomodulatory agent and dexamethasone Cohort 2c: Subject must have received minimum 3 cycles of induction therapy which must contain at minimum, a proteasome inhibitor, an immunomodulatory agent and dexamethasone. Subjects must have had ASCT (single or tandem AND < VGPR (excluding PD) at first assessment between 70 to 110 days after last ASCT, with initial therapy without consolidation and maintenance.
Key exclusion criteria (24 listed)
- Subject used any investigational agents within 14 days prior to leukapheresis or, for Cohort 3, within 14 days prior to consent
- Subject received any of the following within the last 14 days prior to leukapheresis or, for Cohort 3, within 14 days prior to consent:
- Subject with known central nervous system involvement with myeloma
- Subject has clinical evidence of pulmonary leukostasis and disseminated intravascular coagulation
- History or presence of clinically relevant central nervous system (CNS) pathology
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 |
|---|---|---|
| bb2121Also: BMS-986395bb2121 consists of autologous T lymphocytes transduced with an anti-BCMA CAR lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR) | Biological | Cohort 1: BB2121 in relapsed and refractory multiple myeloma participants, Cohort 1b: BB2121 with talquetamab in relapsed and refractory multiple myeloma participants, Cohort 2a: BB2121 in multiple myeloma with Autologous stem cell transplantation participants, Cohort 2b: BB2121 in multiple myeloma without Autologous stem cell transplantation participants, Cohort 2c: BB2121 in multiple myeloma participants with inadequate response post ASCT, Cohort 3: BB2121 with lenalidomide maintenance in newly diagnosed multiple myeloma |
| LenalomideAlso: Revlimid®Specified dose on specified days | Drug | Cohort 3: BB2121 with lenalidomide maintenance in newly diagnosed multiple myeloma |
| TalquetamabAlso: TALVEYSpecified dose on specified days | Drug | Cohort 1b: BB2121 with talquetamab in relapsed and refractory multiple myeloma participants |
Primary outcome
Overall response rate (ORR)- Cohort 1
Time frame: Up to approximately 5 years (Participants will transition to the long term follow-up (LTFU) study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigator
Complete response (CR) rate - Cohort 1b, 2a, 2b, 2c, and Cohort 3
Time frame: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Percentage of subjects who achieved CR or stringent CR according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigator
18 secondary outcomes
Complete response (CR) rate - Cohort 1
Time frame: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Overall response rate (ORR) - Cohort 1b, 2a, b, c and Cohort 3
Time frame: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Very good partial response (VGPR) rate - Cohort 2c
Time frame: Up to approximately 5 years(Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Time to response (TTR)
Time frame: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Duration of response (DoR)
Time frame: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Progression-free survival (PFS)
Time frame: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Time to progression (TTP)
Time frame: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Overall survival (OS)
Time frame: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)
Percentage of participants who received lenalidomide maintenance for the first 3 cycles following bb2121 infusion with at least 75% dose compliance - Cohort 3
Time frame: Up to 3 months
Pharmacokinetics - Cmax
Time frame: Minimum 5 years after bb2121 infusion
Pharmacokinetics - tmax
Time frame: Minimum 5 years after bb2121 infusion
Pharmacokinetics - AUC
Time frame: Minimum 5 years after bb2121 infusion
Pharmacokinetics - tlast
Time frame: Minimum 5 years after bb2121 infusion
Pharmacokinetics - AUC0-28days
Time frame: Minimum 5 years after bb2121 infusion
Immunogenicity
Time frame: Minimum of 2 years after bb2121 infusion
Subject-reported outcomes as measured by European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC-QLQ-C30)
Time frame: Minimum 5 years after bb2121 infusion
Subject-reported outcomes as measured by EuroQoL Group EQ-5D-5L Health Questionnaire
Time frame: Minimum 5 years after bb2121 infusion
Subject-reported outcomes as measured by EORTC-QLQ-MY20
Time frame: Minimum 5 years after bb2121 infusion
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 4 Mar 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bb2121, Lenalomide and Talquetamab in people with Multiple Myeloma, run by Celgene at 25 sites in 6 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 24 inclusion and 24 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 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Germany, Spain, France, Italy and 1 more country. 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?
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?
Overall response rate (ORR)- Cohort 1 (time frame: Up to approximately 5 years (Participants will transition to the long term follow-up (LTFU) study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)). The study lists 2 primary outcomes in all. 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 4 Mar 2026.