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Multiple MyelomaPhase 1KarMMa-7NCT04855136

Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma

A Phase 1 study testing BB2121, CC-220 and BMS-986405 in people with Multiple Myeloma, run by Celgene at 17 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a global, open-label, multi-arm, multi-cohort, multi-center, phase 1/2 study to determine the safety, tolerability, efficacy, PK of bb2121 in combination with other therapies in adult subjects with R/RMM. 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, CC-220 and BMS-986405
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
17 sitesin 2 countries
Study dates
1 Jun 2021to 25 Apr 2025
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

  • Participants must satisfy the following criteria to be enrolled in the study:
  • Participant has documented diagnosis of MM and measurable disease, defined as:
  • M-protein (serum protein electrophoresis [sPEP ≥ 0.5 g/dL] or urine protein electrophoresis [uPEP]): 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 (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Participant has received:
  • at least 3 prior MM regimens for Arm A Cohort 1 and Arm B
Show all 12Show fewer
  • at least 1 but no greater than 3 prior MM regimens for Arm A Cohort 2
  • Arm A Cohort 1 and Arm B: Participant has received prior treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody-containing regimen for at least 2 consecutive cycles.
  • Arm A Cohort 2: Participant has received prior treatment with an immunomodulatory agent for at least 2 consecutive cycles.
  • Evidence of PD during or within 6 months (measured from the last dose of any drug within the regimen) of completing treatment with the last antimyeloma regimen before study entry.
  • Participant achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Who cannot join

  • The presence of any of the following will exclude a participant from enrollment:
  • Participant has non-secretory MM or has history of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
  • Participant has any of the following laboratory abnormalities:
  • ANC and Platelets count as reported below
  • Hemoglobin < 8 g/dL (< 4.9 mmol/L) (transfusion is not permitted within 21 days of screening)
  • Creatinine clearance (CrCl) as reported below
Show all 17Show fewer
  • Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
  • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 ×upper limit of normal (ULN)
  • Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for participants with documented Gilbert's syndrome
  • International normalized ratio (INR) or activated partial thromboplastin time (aPTT) 1.5 × ULN, or history of Grade ≥ 2 hemorrhage within 30 days, or participant requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)
  • Participant has inadequate pulmonary function defined as oxygen saturation (SaO2) < 92% on room air.
  • Participant has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal.
  • Prior exposure to CC-220 (± low-dose dexamethasone) as part of their most recent antimyeloma treatment regimen (Arm A).
  • Prior exposure to BMS-986405 (JSMD194) (Arm B).
  • Previous history of an allogeneic hematopoietic stem cell transplantation, treatment with any gene therapy-based therapeutic for cancer, investigational cellular therapy for cancer or BCMA targeted therapy.
  • Treatment Arm A Cohort 1 and Arm B: participant has received autologous stem cell transplantation (ASCT) within 12 weeks prior to leukapheresis.
  • Treatment Arm A Cohort 2: participant has received autologous stem cell transplantation (ASCT) within 12 months prior to leukapheresis.

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

United States15 sites

  • Local Institution - 104

    Atlanta, Georgia, 30322

  • Local Institution - 120

    Atlanta, Georgia, 30342

  • Local Institution - 117

    Birmingham, Alabama, 10016

  • Local Institution - 108

    Boston, Massachusetts, 02117

  • Local Institution - 124

    Boston, Massachusetts, 02215

  • Local Institution - 111

    Charlotte, North Carolina, 28204

  • Local Institution - 114

    Chicago, Illinois, 60611

  • Local Institution - 109

    Hackensack, New Jersey, 07601

  • Local Institution - 107

    Houston, Texas, 77030

  • Local Institution - 101

    Jacksonville, Florida, 32224-1865

  • Local Institution - 103

    Nashville, Tennessee, 37203

  • New York University Langone

    New York, New York, 10016

  • Local Institution - 110

    New York, New York, 10032

  • Local Institution - 118

    Philadelphia, Pennsylvania, 19107

  • Local Institution - 113

    San Francisco, California, 94143

Other trials in United States

Spain2 sites

  • Local Institution - 201

    Pamplona, 31008

  • Local Institution - 202

    Salamanca, 37007

Other trials in Spain

About this study

Official title: An Exploratory Phase 1/2 Trial to Determine Recommended Phase 2 Dose (RP2D), Safety and Preliminary Efficacy of bb2121 (Ide-cel) Combinations in Subjects With Relapsed/Refractory Multiple Myeloma (KarMMa-7)

This is a global, open-label, multi-arm, multi-cohort, multi-center, phase 1/2 study to determine the safety, tolerability, efficacy, PK of bb2121 in combination with other therapies in adult subjects with R/RMM.

The following combinations will be

  • Arm A will test bb2121 in combination with CC-220 (± low-dose dexamethasone)
  • Arm B will test bb2121 in combination with BMS-986405 (JSMD194)

Combination agents being tested may be administered before, concurrently with and/or following (ie, maintenance) bb2121 infusion.

The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2). Dose expansion may occur in one or more arms.

Being tested
BB2121, CC-220, BMS-986405
Keywords
Relapsed/Refractory Multiple Myeloma, BB2121, ide-cel, CC-220, JSMD194, BMS-986405, DPd, PVd, CAR T, KarMMa-7, Phase I, Phase II, DARA, POM, BTZ
Medical subject headings
Multiple Myeloma

What participants receive

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

  • BB2121Biological

    Also called ide-cel

    CAR T Cell Therapy

  • CC-220Drug

    Cereblon (CRBN) E3 ligase modulatory compound (CELMoD)

  • BMS-986405Drug

    Also called JSMD194

    gamma secretase inhibitor (GSI)

Study groups in NCT04855136
Study groupRoleWhat they receive
Arm A- bb2121 in combination with CC-220 (± low-dose dexamethasone)Experimentalbb2121 will be administered at a target dose of 450 x 10^6 CAR+T cells. The combination agent will be administered at different doses and/ or schedules, depending on dose limiting toxicity (DLT) evaluation.
Receives: Biological: BB2121; Drug: CC-220
Arm B- bb2121 in combination with BMS-986405 (JSMD194)Experimental* bb2121 will be administered at a target dose of 450 x 10^6 CAR+T cells. The combination agent will be administered during Month 1 starting from the day of bb2121 infusion * Enrollment is closed for this Arm
Receives: Biological: BB2121; Drug: BMS-986405

What is being measured

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

  1. Does Limiting Toxicity (DLT) rates _Phase 1

    Percentage of participants experiencing DLTs

    Measured: Up to 28 days from start of the combination therapy

  2. Complete Response Rate (CRR)_ Phase 2

    Proportion of participants who achieved CR or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by investigator's review

    Measured: Up to 24 months

Secondary outcomes (14)

  1. Incidence of Adverse Event (AEs)

    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

    Measured: Up to 24 months after the last participant received any study treatment

  2. Overall Response Rate (ORR)

    Proportion of participants who achieved PR or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed investigator's review

    Measured: Up to 24 months after the last participant received any study treatment in the respective cohort

  3. Progression-free Survival (PFS)

    Time from first study treatment (whichever is given earlier) start date to the date of either first observation of progressive disease or death due to any cause

    Measured: Up to 24 months after the last participant received any study treatment in the respective cohort

  4. Overall Survival (OS)

    Time from first study treatment (whichever is given earlier) start date to death due to any cause

    Measured: Up to 24 months after the last participant received any study treatment in the respective cohort

  5. Time to response (TTR)

    Time from first study treatment start date to the first date of documented response (PR or better)

    Measured: Up to 24 months after the last participant received any study treatment in the respective cohort

  6. Duration of Response (DoR)

    Time from first documentation of response (PR or better) to first documentation of PD or death due to any cause

    Measured: Up to 24 months after the last participant received any study treatment in the respective cohort

  7. Time to next antimyeloma treatment (TTNT)

    Time from first study treatment (whichever is given earlier) start date to first day when participant receives another antimyeloma treatment

    Measured: Up to 24 months after the last participant received any study treatment in the respective cohort

  8. Progression-free survival after next antimyeloma therapy (PFS2)

    Time from first study treatment (whichever is given earlier) start date to documentation of PD on the next-line treatment or death from any cause, whichever is first.

    Measured: Up to 24 months after the last participant received any study treatment in the respective cohort

  9. Feasibility of maintenance therapy in combination with bb2121

    Cumulative incidence of the maintenance therapy starting from bb2121 infusion with death as the competing risk

    Measured: Up to 4 months after bb2121 infusion in the respective cohort

  10. Pharmacokinetics - Cmax_Phase 1 and 2

    Maximum transgene level

    Measured: Up to 24 months after the last participant received any study treatment in the respective cohort

  11. Pharmacokinetics - Tmax_Phase 1 and 2

    Time to maximum observed transgene level

    Measured: Up to 24 months after the last participant received any study treatment in the respective cohort

  12. Pharmacokinetics - AUC_Phase 1 and 2

    Area under the curve of transgene level

    Measured: Up to 24 months after the last participant received any study treatment in the respective cohort

  13. Pharmacokinetics - AUC0-28days _Phase 1 and 2

    Area under the curve of transgene level from time 0 to 28 days

    Measured: Up to 24 months after the last participant received any study treatment in the respective cohort

  14. Pharmacokinetics - Tlast _Phase 1 and 2

    Time of last measurable transgene level

    Measured: Up to 24 months after the last participant received any study treatment in the respective cohort

Timeline

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

  1. First posted22 Apr 2021
  2. Study start1 Jun 2021
  3. Primary completion25 Apr 2025
  4. Study completion25 Apr 2025

Why it stopped: Business objectives have changed

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04855136
Sponsor's protocol ID
BB2121-MM-007
Other IDs
2020-003248-10
Acronym
KarMMa-7
Status last verified
Jul 2026
First submitted
19 Apr 2021
Last updated
9 Jul 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/disclosurecommitment.html

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BB2121, CC-220 and BMS-986405 in people with Multiple Myeloma, run by Celgene at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 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: stopped early, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Spain. 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 was stopped early (reason given: Business objectives have changed). Results are not available in the source record.

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?

Does Limiting Toxicity (DLT) rates _Phase 1 (time frame: Up to 28 days from start of the combination therapy). 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?

On the ClinicalTrials.gov record for NCT04855136.

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 9 Jul 2026.

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