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Multiple MyelomaPhase 3KarMMa-3NCT03651128

Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

A Phase 3 study testing bb2121, Daratumumab and Pomalidomide in people with Multiple Myeloma, run by Celgene at 62 sites in 13 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM). The study is anticipated to randomize approximately 381 subjects with RRMM. 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, Daratumumab and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
386 participants
Where
62 sitesin 13 countries
Study dates
16 Apr 2019to 13 Apr 2026
Phase
Phase 3
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).
  • Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements within this protocol and for a subject randomized to Treatment Arm A, subject agrees to continued follow-up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials.
  • Subject has documented diagnosis of MM and 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
Show all 22Show fewer
  • 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
  • Subject has received at least 2 but no greater than 4 prior MM regimens.
  • Subject has received prior treatment with DARA, a proteasome inhibitor- and an immunomodulatory compound-containing regimen for at least 2 consecutive cycles.
  • Subject must be refractory to the last treatment regimen. Refractory is defined as documented progressive disease during or within 60 days (measured from the last dose of any drug within the regimen) of completing treatment with the last anti-myeloma regimen before study entry.
  • Subject achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 peripheral neuropathy.
  • Adequate vascular access for leukapheresis
  • Females of childbearing potential (FCBP) must:
  • Have negative pregnancy test(s) as verified by the Investigator. This applies even if the subject practices true abstinence from heterosexual contact.
  • Either practice true abstinence from heterosexual contact or agree to use, and be able to comply with, effective measures of contraception without interruption.
  • Agree to abstain from breastfeeding during study participation. d. Refrain from tissue donation including egg cell donation or any other tissue/blood/organ donations.
  • Male subjects must:
  • Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, even if he has undergone a successful vasectomy.
  • Refrain from tissue donation including sperm or any other tissue/blood/organ donations.
  • Only subjects that would be considered for any of the 5 proposed standard regimens (DPd, DVd, IRd, Kd, or EPd), as judged by the investigator, should be included in the study.

Who cannot join

  • The presence of any of the following will exclude a subject from enrollment:
  • Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  • Subject has any condition that confounds the ability to interpret data from the study.
  • Subject has nonsecretory multiple myeloma (MM).
  • Subject has any of the following laboratory abnormalities:
Show all 40Show fewer
  • Absolute neutrophil count (ANC) < 1,000/μL b. Platelet count: < 75,000/μL in subjects in whom < 50% of bone marrow nucleated cells are plasma cells and platelet count < 50,000/μL in subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells (it is not permissible to transfuse a subject to reach this level) c. Hemoglobin < 8 g/dL (< 4.9 mmol/L) (it is not permissible to transfuse a subject to reach this level) d. Serum creatinine clearance (CrCl) < 45 mL/min e. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L) f. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN) g. Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome h. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) > 1.5 × ULN, or history of Grade ≥ 2 hemorrhage within 30 days, or subject requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)
  • Subject has inadequate pulmonary function defined as oxygen saturation (SaO2) < 92% on room air.
  • Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years • Basal cell carcinoma of the skin
  • Squamous cell carcinoma of the skin
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system) or prostate cancer that can be treated with curative intent
  • Subject has active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome or amyloidosis.
  • Subject with known central nervous system (CNS) involvement with myeloma.
  • Subject has clinical evidence of pulmonary leukostasis and disseminated intravascular coagulation.
  • Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal.
  • Subject has a history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
  • Subject was treated with DARA in combination with POM with or without dex (DP±d) as part of their most recent anti-myeloma treatment regimen, cannot receive DPd as bridging therapy but may receive DVd, IRd, Kd or EPdas bridging as per Investigator's discretion if randomized to Treatment Arm A.
  • Subject was treated with DP±d as part of their most recent anti-myeloma treatment regimen, cannot receive DPd if randomized to Treatment Arm B but may receive DVd, IRd, Kd, or EPd as per Investigator's discretion.
  • Subject was treated with DARA in combination with BTZ with or without dexamethasone (DV±d) as part of their most recent anti-myeloma treatment regimen, cannot receive DVd as bridging therapy but may receive DPd, IRd, Kd, or EPd as bridging as per Investigator's discretion if randomized to Treatment Arm A.
  • Subject was treated with DV±d as part of their most recent anti-myeloma treatment regimen, cannot receive DVd if randomized to Treatment Arm B but may receive DPd, IRd, Kd, or EPd as per Investigator's discretion.
  • Subject was treated with IXA in combination with LEN with or without dexamethasone (IR±d) as part of their most recent anti-myeloma treatment regimen, cannot receive IRd as bridging therapy but may receive DPd, DVd, Kd, or EPd as bridging as per Investigator's discretion if randomized to Treatment Arm A.
  • Subject was treated with IR±d as part of their most recent anti-myeloma treatment regimen, cannot receive IRd if randomized to Treatment Arm B but may receive DPd, DVd, Kd, or EPd as per Investigator's discretion.
  • 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.
  • Subject has received autologous stem cell transplantation (ASCT) within 12 weeks prior to randomization.
  • Subject has received any of the following within the last 14 days prior to randomization:
  • Plasmapheresis b. Major surgery (as defined by the Investigator) c. Radiation therapy other than local therapy for myeloma-associated bone lesions d. Use of any investigational agents and systemic anti-myeloma drug therapy
  • Echocardiogram (ECHO) or multigated acquisition (MUGA) with left ventricular ejection fraction (LVEF) < 45%.
  • Ongoing treatment with chronic immunosuppressants (eg, cyclosporine or systemic steroids at any dose). Intermittent topical, inhaled or intranasal corticosteroids are allowed.
  • Subject is positive for human immunodeficiency virus (HIV-1 and HIV-2), chronic or active hepatitis B or active hepatitis A or C.
  • Subject has uncontrolled systemic fungal, bacterial, viral or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antimicrobial treatment) or requiring IV antimicrobials for management.
  • Subject has 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 randomization.
  • Hypersensitivity to DARA, thalidomide, lenalidomide, POM, BTZ, IXA, CFZ, ELO or dexamathasone. This includes rash ≥ Grade 3 during prior thalidomide, POM or lenalidomide therapy.
  • Subject with known hypersensitivity to any component of bb2121 product, cyclophosphamide, fludarabine, and/or tocilizumab or hypersensitivity to the excipients contained in the formulation of DARA, POM, LEN, IXA, BTZ, CFZ, ELO or dexamethasone.
  • Subject is a female who is pregnant, nursing, or breastfeeding
  • For a subject randomized to Treatment Arm B and will be on a POM- or LEN-containing regimen; unable or unwilling to undergo protocol required thromboembolism prophylaxis.
  • 28 Subject is intolerant to bortezomib, or has acute diffuse infiltrative pulmonary and pericardial disease, subject cannot receive DVd as bridging therapy if randomized to Treatment Arm A or cannot receive DVd if randomized to Treatment Arm B.
  • 31. Subject was treated with K±d as part of their most recent anti-myeloma treatment regimen, cannot receive Kd if randomized to Treatment Arm B but may receive DPd, DVd, IRd or EPd as per Investigator's discretion.
  • 32. Subject was treated with EP±d as part of their most recent anti-myeloma treatment regimen, cannot receive EPd if randomized to Treatment Arm B but may receive DPd, DVd, Kd or IRd as per Investigator's discretion.

Trial locations and contacts

62 sites in 13 countries.

62 sites in 13 countries

United States36 sites

  • Local Institution - 120

    Ann Arbor, Michigan, 48109-5936

  • Local Institution - 131

    Atlanta, Georgia, 30322

  • Local Institution - 140

    Atlanta, Georgia, 30342

  • Local Institution - 142

    Aurora, Colorado, 80045

  • Local Institution - 104

    Baltimore, Maryland, 21201-1595

  • Local Institution - 109

    Birmingham, Alabama, 10016

  • Local Institution - 134

    Boston, Massachusetts, 02114

  • Local Institution - 123

    Boston, Massachusetts, 02215

  • Local Institution - 139

    Chicago, Illinois, 60611

  • Local Institution - 118

    Dallas, Texas, 75246

  • Local Institution - 103

    Dallas, Texas, 75390

  • Local Institution - 113

    Durham, North Carolina, 27705

  • Local Institution - 138

    Hackensack, New Jersey, 07601

  • Local Institution - 132

    Houston, Texas, 77030

  • Local Institution - 100

    Indianapolis, Indiana, 46202-528

  • Local Institution - 108

    Jacksonville, Florida, 32224

  • Local Institution - 145

    Los Angeles, California, 90048

  • Local Institution - 122

    Los Angeles, California, 90095

  • Local Institution - 107

    Madison, Wisconsin, 53792

  • Froedtert Hospital BMT Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Local Institution - 106

    Nashville, Tennessee, 37203

  • Local Institution - 119

    New York, New York, 10029

  • Local Institution - 115

    New York, New York, 10065

  • Local Institution - 135

    New York, New York, 10065

  • University Of Nebraska

    Omaha, Nebraska, 68198-7680

  • Local Institution - 124

    Palo Alto, California, 94304

  • Local Institution - 111

    Philadelphia, Pennsylvania, 19107

  • Local Institution - 110

    Philadelphia, Pennsylvania, 19111

  • Local Institution - 101

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 125

    Rochester, Minnesota, 55905-0001

  • Local Institution - 136

    Salt Lake City, Utah, 84112

  • Local Institution - 141

    Scottsdale, Arizona, 85259

  • Local Institution - 105

    Seattle, Washington, 98104

  • Local Institution - 114

    St Louis, Missouri, 63110

  • Local Institution - 102

    Tampa, Florida, 33612

  • Local Institution - 112

    Westwood, Kansas, 66205-2003

Other trials in United States

Germany5 sites

  • Local Institution - 515

    Cologne, 50937

  • Local Institution - 513

    Düsseldorf, 40225

  • Local Institution - 514

    Hamburg, 20246

  • Local Institution - 512

    Heidelberg, 69120

  • Local Institution - 511

    Würzburg, 97080

Other trials in Germany

France4 sites

  • Local Institution - 402

    Lille, 59037

  • Local Institution - 403

    Nantes, 44093

  • Local Institution - 400

    Paris, 75010

  • Local Institution - 401

    Toulouse, 31059

Other trials in France

Japan4 sites

  • Local Institution - 806

    Bunkyō City, 113-8677

  • Local Institution - 804

    Isehara City, Kanagawa, 259-1193

  • Local Institution - 807

    Nagoya, 467-8602

  • Local Institution - 805

    Shibuya-ku, 150-8935

Other trials in Japan

Canada2 sites

  • Local Institution - 302

    Calgary, Alberta, T2N 4N2

  • Local Institution - 303

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Netherlands2 sites

  • Local Institution - 650

    Amsterdam, 1081 HV

  • Local Institution - 651

    Rotterdam, 3015 CN

Other trials in Netherlands

Spain2 sites

  • Local Institution - 750

    Pamplona, 31008

  • Local Institution - 751

    Salamanca, 37007

Other trials in Spain

United Kingdom2 sites

  • Local Institution - 850

    Leeds, LS9 7TF

  • Local Institution - 851

    London, SE5 9RS

Other trials in United Kingdom

Belgium1 site

  • Local Institution - 202

    Leuven, 3000

Other trials in Belgium

Italy1 site

  • Local Institution - 611

    Bologna, 40138

Other trials in Italy

Norway1 site

  • Local Institution - 700

    Oslo, N-0027

Other trials in Norway

Sweden1 site

  • Local Institution - 800

    Stockholm, SE-141 86

Other trials in Sweden

Switzerland1 site

  • Local Institution - 251

    Bern, 3010

Other trials in Switzerland

About this study

Official title: A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM).

The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.

Keywords
Multiple Myeloma, bb2121, Relapsed and Refractory Multiple Myeloma, High Risk Multiple Myeloma
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.

Study groups in NCT03651128
Study groupRoleWhat they receive
Arm A - Administration of bb2121Experimentalbb2121 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
Arm B- standard regimens as per Investigator's discretionExperimentalThe participants will receive one of following regimens dependent on the subject's most recent anti-myeloma treatment regimen: * Daratumumab (DARA) in combination with pomalidomide (POM) and low-dose dexamethasone (dex) (DPd) OR * DARA in combination with bortezomib (BTZ) and low-dose dex (DVd) OR * Ixazomib (IXA) in combination with lenalidomide (LEN) and low-dose dex (IRd) OR * Carfilzomib (CFZ) in combination with low-dose dexamethasone (Kd) OR * Elotuzumab (ELO) in combination with POM and low-dose dexamethasone (EPd)
Receives: Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Bortezomib; Drug: Ixazomib; Drug: Lenalidomide; Drug: Carfilzomib; Drug: Elotuzumab

What is being measured

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

  1. Progression-free Survival (PFS)

    Time from randomization to the first documentation of progressive disease based on the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma assessed by an independent response committee (IRC) or death due to any cause, whichever occurs first.

    Measured: Minimum of 5 years from randomization

Secondary outcomes (18)

  1. Overall Survival (OS)

    Time from randomization to time of death due to any cause

    Measured: Minimum of 5 years from randomization

  2. Event-free Survival (EFS)

    Time from randomization to the first documentation of progressive disease, first day when subject receives another anti-myeloma treatment or death due to any cause, whichever occurs first

    Measured: Minimum of 5 years from randomization

  3. Overall Response Rate (ORR)

    Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an IRC

    Measured: Minimum of 5 years from randomization

  4. Minimal Residual Disease (MRD)

    Percentage of MRD evaluable subjects that are MRD negative (defined at a minimum of 1 in 10^5 nucleated cells) using flow cytometry (EuroFlow) and next generation sequencing (NGS)

    Measured: Minimum of 5 years from randomization

  5. Complete Response (CR) Rate

    Percentage of subjects who achieved CR or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an IRC

    Measured: Minimum of 5 years from randomization

  6. Duration of Response (DOR)

    Time from first documentation of response (PR or better) to first documentation of disease progression or death from any cause, whichever occurs first

    Measured: Minimum of 5 years from randomization

  7. Time to Response (TTR)

    TTR is calculated as the time from randomization to the initial documented response (PR or better) based on IMWG guideline for responders

    Measured: Minimum of 5 years from randomization

  8. Adverse Events (AEs)

    Number of participants with adverse events

    Measured: Minimum of 5 years from randomization

  9. Pharmacokinetics- Cmax

    Maximum peak in bb2121 chimeric antigen receptor (CAR) T cells

    Measured: Minimum 5 years after bb2121 infusion

  10. Pharmacokinetics- tmax

    Time to peak of bb2121 CAR T cells

    Measured: Minimum 5 years after bb2121 infusion

  11. Pharmacokinetics- AUC

    Area under the curve of CAR T cells

    Measured: Minimum 5 years after bb2121 infusion

  12. Pharmacokinetics- t-last

    Time to last measurable CAR T cells

    Measured: Minimum 5 years after bb2121 infusion

  13. Pharmacokinetics- AUC0-28days

    Area under the curve of CAR T cells from time zero to Day 28

    Measured: Minimum 5 years after bb2121 infusion

  14. 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 of 5 years from randomization

  15. Subject-reported outcomes as measured by EuroQoL Group European Quality of Life-5 Dimensions health state classifier to 5 Levels (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 of 5 years from randomization

  16. Subject-reported outcomes as measured by European Quality of Life Multiple Myeloma Module (EORTC-QLQ-MY20)

    Is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality

    Measured: Minimum of 5 years from randomization

  17. Time to next antimyeloma treatment

    Time from randomization to first day when subject receives another anti-myeloma treatment

    Measured: Minimum of 5 years from randomization

  18. Progression-free survival after next line therapy (PFS2)

    Time from randomization to second objective disease progression or death from any cause, whichever is first

    Measured: Minimum of 5 years from randomization

Timeline

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

  1. First posted29 Aug 2018
  2. Study start16 Apr 2019
  3. Primary completion13 Apr 2026
  4. Study completion13 Apr 2026

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
386 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03651128
Sponsor's protocol ID
BB2121-MM-003
Other IDs
U1111-1217-9988, 2018-001023-38, 2018
Acronym
KarMMa-3
Status last verified
Jun 2026
First submitted
16 Aug 2018
Last updated
22 Jun 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

Publications

  • Lopez-Munoz N, Bar N, Diels J, van Sanden S, Mendes J, Lee S, Hernando T, Lendvai N, Patel N, Ishida T, Er J, Harrison SJ. Ciltacabtagene Autoleucel Versus Idecabtagene Vicleucel in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma with 2-4 Prior Lines of Therapy: Updated Matching-Adjusted Indirect Comparison. Adv Ther. 2026 Mar;43(3):1327-1340. doi: 10.1007/s12325-025-03479-y. Epub 2026 Feb 2.

    PubMed 41627370

  • Ailawadhi S, Arnulf B, Patel K, Cavo M, Nooka AK, Manier S, Callander N, Costa LJ, Vij R, Bahlis NJ, Moreau P, Solomon S, Abrahamsen IW, Baz R, Broijl A, Chen C, Jagannath S, Raje N, Scheid C, Delforge M, Benjamin R, Pabst T, Iida S, Berdeja J, Giralt S, Truppel-Hartmann A, Chen Y, Zhong X, Wu F, Piasecki J, Eliason L, Dhanda D, Felten J, Caia A, Cook M, Popa McKiver M, Rodriguez-Otero P. Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: updated KarMMa-3 analyses. Blood. 2024 Dec 5;144(23):2389-2401. doi: 10.1182/blood.2024024582.

    PubMed 39197072

  • Rodriguez-Otero P, Ailawadhi S, Arnulf B, Patel K, Cavo M, Nooka AK, Manier S, Callander N, Costa LJ, Vij R, Bahlis NJ, Moreau P, Solomon SR, Delforge M, Berdeja J, Truppel-Hartmann A, Yang Z, Favre-Kontula L, Wu F, Piasecki J, Cook M, Giralt S. Plain language summary of the KarMMa-3 study of ide-cel or standard of care regimens in people with relapsed or refractory multiple myeloma. Future Oncol. 2024;20(18):1221-1235. doi: 10.2217/fon-2023-0954. Epub 2024 Apr 23.

    PubMed 38651976

  • Rodriguez-Otero P, Ailawadhi S, Arnulf B, Patel K, Cavo M, Nooka AK, Manier S, Callander N, Costa LJ, Vij R, Bahlis NJ, Moreau P, Solomon SR, Delforge M, Berdeja J, Truppel-Hartmann A, Yang Z, Favre-Kontula L, Wu F, Piasecki J, Cook M, Giralt S. Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2023 Mar 16;388(11):1002-1014. doi: 10.1056/NEJMoa2213614. Epub 2023 Feb 10.

    PubMed 36762851

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bb2121, Daratumumab and Pomalidomide in people with Multiple Myeloma, run by Celgene at 62 sites in 13 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 22 inclusion and 40 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 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Germany, France, Japan, Canada and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression-free Survival (PFS) (time frame: Minimum of 5 years from randomization). 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 NCT03651128, which also lists 4 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 22 Jun 2026.

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