KarMMa-3: Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

• Sponsor: Celgene (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03651128
• Collaborator: (none)
• Enrollment: 381
• Locations: 105
• Arms: 2
• Anticipated Duration (Months): 89.2
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Biological: bb2121; Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Bortezomib; Drug: Ixazomib; Drug: Lenalidomide; Drug: Carfilzomib; Drug: Elotuzumab	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 381 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Apr 16, 2019
• Anticipated Primary Completion Date: Sep 22, 2026
• Anticipated Study Completion Date: Sep 22, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A - Administration of bb2121 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	Biological: bb2121; bb2121
Experimental: Arm B- standard regimens as per Investigator's discretion The 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)	Drug: Daratumumab; Daratumumab; Drug: Pomalidomide; Pomalidomide; Drug: Dexamethasone; Dexamethasone; Drug: Bortezomib; Bortezomib; Drug: Ixazomib; Ixazomib; Drug: Lenalidomide; Lenalidomide; Drug: Carfilzomib; Carfilzomib; Drug: Elotuzumab; Elotuzumab

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival (PFS) [Minimum of 5 years from randomization]

   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.

Secondary Outcome Measures

1. Overall Survival (OS) [Minimum of 5 years from randomization]

   Time from randomization to time of death due to any cause

2. Event-free Survival (EFS) [Minimum of 5 years from randomization]

   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

3. Overall Response Rate (ORR) [Minimum of 5 years from randomization]

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

4. Minimal Residual Disease (MRD) [Minimum of 5 years from randomization]

   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)

5. Complete Response (CR) Rate [Minimum of 5 years from randomization]

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

6. Duration of Response (DOR) [Minimum of 5 years from randomization]

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

7. Time to Response (TTR) [Minimum of 5 years from randomization]

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

8. Adverse Events (AEs) [Minimum of 5 years from randomization]

   Number of participants with adverse events

9. Pharmacokinetics- Cmax [Minimum 5 years after bb2121 infusion]

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

10. Pharmacokinetics- tmax [Minimum 5 years after bb2121 infusion]

    Time to peak of bb2121 CAR T cells

11. Pharmacokinetics- AUC [Minimum 5 years after bb2121 infusion]

    Area under the curve of CAR T cells

12. Pharmacokinetics- t-last [Minimum 5 years after bb2121 infusion]

    Time to last measurable CAR T cells

13. Pharmacokinetics- AUC0-28days [Minimum 5 years after bb2121 infusion]

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

14. Subject-reported outcomes as measured by European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC-QLQ-C30) [Minimum of 5 years from randomization]

    Questionnaire will be used as a measure of health-related quality of life

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 [Minimum of 5 years from randomization]

    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

16. Subject-reported outcomes as measured by European Quality of Life Multiple Myeloma Module (EORTC-QLQ-MY20) [Minimum of 5 years from randomization]

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

17. Time to next antimyeloma treatment [Minimum of 5 years from randomization]

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

18. Progression-free survival after next line therapy (PFS2) [Minimum of 5 years from randomization]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).

2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.

3. 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.

4. 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

• 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

1. Subject has received at least 2 but no greater than 4 prior MM regimens.

2. Subject has received prior treatment with DARA, a proteasome inhibitor- and an immunomodulatory compound-containing regimen for at least 2 consecutive cycles.

3. 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.

4. Subject achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen.

5. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

6. Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 peripheral neuropathy.

7. Adequate vascular access for leukapheresis

8. Females of childbearing potential (FCBP) must:

1. Have negative pregnancy test(s) as verified by the Investigator. This applies even if the subject practices true abstinence from heterosexual contact.

2. Either practice true abstinence from heterosexual contact or agree to use, and be able to comply with, effective measures of contraception without interruption.

3. Agree to abstain from breastfeeding during study participation. d. Refrain from tissue donation including egg cell donation or any other tissue/blood/organ donations.

1. Male subjects must:

1. 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.

2. Refrain from tissue donation including sperm or any other tissue/blood/organ donations.

1. 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.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

2. 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.

3. Subject has any condition that confounds the ability to interpret data from the study.

4. Subject has nonsecretory multiple myeloma (MM).

5. Subject has any of the following laboratory abnormalities:

1. 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)

1. Subject has inadequate pulmonary function defined as oxygen saturation (SaO2) < 92% on room air.

2. 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

1. Subject has active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome or amyloidosis.

2. Subject with known central nervous system (CNS) involvement with myeloma.

3. Subject has clinical evidence of pulmonary leukostasis and disseminated intravascular coagulation.

4. Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. Subject has received autologous stem cell transplantation (ASCT) within 12 weeks prior to randomization.

14. Subject has received any of the following within the last 14 days prior to randomization:

1. 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

1. Echocardiogram (ECHO) or multigated acquisition (MUGA) with left ventricular ejection fraction (LVEF) < 45%.

2. Ongoing treatment with chronic immunosuppressants (eg, cyclosporine or systemic steroids at any dose). Intermittent topical, inhaled or intranasal corticosteroids are allowed.

3. Subject is positive for human immunodeficiency virus (HIV-1 and HIV-2), chronic or active hepatitis B or active hepatitis A or C.

4. 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.

5. 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.

6. Hypersensitivity to DARA, thalidomide, lenalidomide, POM, BTZ, IXA, CFZ, ELO or dexamathasone. This includes rash ≥ Grade 3 during prior thalidomide, POM or lenalidomide therapy.

7. 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.

8. Subject is a female who is pregnant, nursing, or breastfeeding

9. 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.

1. 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.

2. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution - 109	Birmingham	Alabama	United States	10016
2	University of Alabama Birmingham	Birmingham	Alabama	United States	10016
3	Local Institution - 141	Scottsdale	Arizona	United States	85259
4	Mayo Clinic Arizona	Scottsdale	Arizona	United States	85259
5	Local Institution - 122	Los Angeles	California	United States	90095
6	UCLA Medical Centre-Santa Monica Hematology and Oncology	Los Angeles	California	United States	90095
7	Local Institution - 142	Aurora	Colorado	United States	80045
8	University of Colorado Anschutz Cancer Pavilion	Aurora	Colorado	United States	80045
9	Local Institution - 108	Jacksonville	Florida	United States	32224
10	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
11	Local Institution - 102	Tampa	Florida	United States	33612
12	Moffit Cancer Center	Tampa	Florida	United States	33612
13	Emory University Hospital	Atlanta	Georgia	United States	30322
14	Local Institution - 131	Atlanta	Georgia	United States	30322
15	Blood and Marrow Transplant Group of Georgia	Atlanta	Georgia	United States	30342
16	Local Institution - 140	Atlanta	Georgia	United States	30342
17	Local Institution - 139	Chicago	Illinois	United States	60611
18	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611
19	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-528
20	Local Institution - 100	Indianapolis	Indiana	United States	46202-528
21	Local Institution - 112	Westwood	Kansas	United States	66205-2003
22	The University of Kansas Hospital	Westwood	Kansas	United States	66205-2003
23	Greenebaum University of Maryland	Baltimore	Maryland	United States	21201-1595
24	Local Institution - 104	Baltimore	Maryland	United States	21201-1595
25	Local Institution - 134	Boston	Massachusetts	United States	02114
26	Mass General	Boston	Massachusetts	United States	02114
27	Dana Farber Cancer Institute (DFCI)	Boston	Massachusetts	United States	02215
28	Local Institution - 123	Boston	Massachusetts	United States	02215
29	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-5936
30	Local Institution - 125	Rochester	Minnesota	United States	55905-0001
31	Mayo Clinic - Rochester	Rochester	Minnesota	United States	55905
32	Local Institution - 114	Saint Louis	Missouri	United States	63110
33	Washington University School of Medicine, Siteman Cancer Center	Saint Louis	Missouri	United States	63110
34	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
35	Local Institution - 138	Hackensack	New Jersey	United States	07601
36	Local Institution - 119	New York	New York	United States	10029
37	Mount Sinai Medical Center	New York	New York	United States	10029
38	Local Institution - 115	New York	New York	United States	10065
39	Local Institution - 135	New York	New York	United States	10065
40	New York Presbyterian Hospital Weil Cornell Medical College	New York	New York	United States	10065
41	Duke Clinical Research Institute Duke University School of Medicine	Durham	North Carolina	United States	27705
42	Local Institution - 113	Durham	North Carolina	United States	27705
43	Local Institution - 111	Philadelphia	Pennsylvania	United States	19107
44	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
45	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
46	Local Institution - 110	Philadelphia	Pennsylvania	United States	19111
47	University of Pittsburgh Medical Center - William M. Cooper Ambulatory Care Pavilion	Pittsburgh	Pennsylvania	United States	15232
48	University of Pittsburgh Medical Center William M. Cooper Ambulatory Care Pavillion	Pittsburgh	Pennsylvania	United States	15232
49	Sarah Cannon Research Institute Center for Blood	Nashville	Tennessee	United States	37203:
50	Baylor University Medical Center at Dallas	Dallas	Texas	United States	75246
51	Local Institution - 118	Dallas	Texas	United States	75246
52	Local Institution - 103	Dallas	Texas	United States	75390
53	Local Institution - 132	Houston	Texas	United States	77030
54	MD Anderson Cancer center	Houston	Texas	United States	77030
55	Local Institution - 136	Salt Lake City	Utah	United States	84112
56	University of Utah Huntsman Cancer Center	Salt Lake City	Utah	United States	84112
57	Swedish Cancer Institute	Seattle	Washington	United States	98104
58	Local Institution - 107	Madison	Wisconsin	United States	53792
59	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin	United States	53792
60	Local Institution - 202	Leuven		Belgium	3000
61	UZ Leuven	Leuven		Belgium	3000
62	Local Institution - 302	Calgary	Alberta	Canada	T2N 4N2
63	Tom Baker Cancer center	Calgary	Alberta	Canada	T2N 4N2
64	Local Institution - 303	Toronto	Ontario	Canada	M5G 2M9
65	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9
66	CHRU Lille	Lille Cedex		France	59037
67	Local Institution - 402	Lille Cedex		France	59037
68	Centre Hospitalier Univ De Nantes Hotel-Dieu	Nantes		France	44093
69	Local Institution - 403	Nantes		France	44093
70	Hospital Saint-Louis - APHP	Paris		France	75010
71	Local Institution - 400	Paris		France	75010
72	IUCT Oncopole	Toulouse CEDEX 9		France	31059
73	Local Institution - 401	Toulouse CEDEX 9		France	31059
74	Local Institution - 513	Dusseldorf		Germany	40225
75	Local Institution - 514	Hamburg		Germany	20246
76	Local Institution - 512	Heidelberg		Germany	69120
77	Medizinische Universitaetsklinik Heidelberg	Heidelberg		Germany	69120
78	Local Institution - 515	Köln		Germany	50937
79	Universitat zu Koln	Köln		Germany	50937
80	Local Institution - 511	Würzburg		Germany	97080
81	Universitaetsklinikum Wuerzburg	Würzburg		Germany	97080
82	Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematolog	Bologna		Italy	40138
83	Local Institution - 611	Bologna		Italy	40138
84	Local Institution - 806	Bunkyo-ku		Japan	113-8677
85	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital	Bunkyo-ku		Japan	113-8677
86	Local Institution - 804	Isehara City, Kanagawa		Japan	259-1193
87	Tokai University Hospital	Isehara, Kanagawa		Japan	259-1193
88	Local Institution - 807	Nagoya		Japan	467-8602
89	Japan Red Cross Medical Center	Shibuya-ku		Japan	150-8935
90	Local Institution - 805	Shibuya-ku		Japan	150-8935
91	Local Institution - 650	Amsterdam		Netherlands	1081 HV
92	Erasmus Medical Center	Rotterdam		Netherlands	3015 CN
93	Local Institution - 651	Rotterdam		Netherlands	3015 CN
94	Oslo universitetssykehus, Rikshospitalet	Oslo Universitetssykehus, Rikshospitalet		Norway	N-0027
95	Local Institution - 700	Oslo		Norway	N-0027
96	Clinica Universidad de Navarra	Pamplona		Spain	31008
97	Local Institution - 750	Pamplona		Spain	31008
98	Hospital Universitario de Salamanca	Salamanca		Spain	37007
99	Local Institution - 751	Salamanca		Spain	37007
100	Karolinska Universitetssjukhuset - Huddinge	Stockholm		Sweden	SE-141 86
101	Local Institution - 251	Bern		Switzerland	3010
102	Universitaetsspital Bern - Inselspital	Bern		Switzerland	3010
103	Local Institution - 850	Leeds		United Kingdom	LS9 7TF
104	Kings College Hospital	London		United Kingdom	SE5 9RS
105	Local Institution - 851	London		United Kingdom	SE5 9RS

Sponsors and Collaborators

• Celgene

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT03651128
• Other Study ID Numbers: BB2121-MM-003; U1111-1217-9988; 2018-001023-38
• First Posted: Aug 29, 2018
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Celgene: Multiple Myeloma; bb2121; Relapsed and Refractory Multiple Myeloma; High Risk Multiple Myeloma
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Dexamethasone; Lenalidomide; Bortezomib; Daratumumab; Pomalidomide; Ixazomib; Elotuzumab

Study Results

No Results Posted as of Aug 2, 2022