Multiple Myeloma Clinical Trial

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

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.

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)
Arm C will test bb2121 in combination with one of the following standard triplet regimens: 1) Daratumumab (DARA) in combination with pomalidomide (POM) and low-dose dexamethasone (DPd); 2) Pomalidomide (POM) in combination with bortezomib (BTZ) and low-dose dexamethasone (PVd)

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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] 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

Participant has received:

at least 3 prior MM regimens for Arm A Cohort 1 and Arm B
at least 1 but no greater than 3 prior MM regimens for Arm A Cohort 2 and Arm C.
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 and Arm C: 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.

Exclusion Criteria:

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
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).
Prior exposure to DARA in combination with POM with or without dexamethasone (DP±d) as part of their most recent antimyeloma treatment regimen (Arm C Cohort 1).
Prior exposure to POM in combination with BTZ with or without dexamethasone (PV± d as part of their most recent antimyeloma treatment regimen (Arm C Cohort 2).
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 Arms A Cohort 2 and Arm C: participant has received autologous stem cell transplantation (ASCT) within 12 months prior to leukapheresis.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

415

Study ID:

NCT04855136

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 23 Locations for this study

See Locations Near You

University of Alabama Birmingham
Birmingham Alabama, 10016, United States
University of Alabama Birmingham
Birmingham Alabama, 10016, United States More Info
Susan Bal, Site 117
Contact
205-934-1908
University of California, San Francisco- California
San Francisco California, 94143, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States More Info
Sikander Ailawadhi, Site 101
Contact
904-953-2000
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States More Info
Sagar Lonial, Site 104
Contact
404-778-1900
Northside Hospital, Inc
Atlanta Georgia, 30342, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
Massachusetts General Hospital
Boston Massachusetts, 02117, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States More Info
David Avigan, Site 124
Contact
617-794-9101
The Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
New York University Langone
New York New York, 10016, United States
Weill Cornell Medicine / New York Presbyterian Hospital
New York New York, 10021, United States
Icahn School of Medicine at Mount Sinai Medical Center
New York New York, 10029, United States
Columbia University Medical Center
New York New York, 10032, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
Kimmel Cancer Center Thomas Jefferson Univ
Philadelphia Pennsylvania, 19107, United States
Kimmel Cancer Center Thomas Jefferson Univ
Philadelphia Pennsylvania, 19107, United States More Info
Usama Gergis, Site 118
Contact
212-746-6736
Sarah Cannon Research Institute Center for Blood Cancers
Nashville Tennessee, 37203, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
University of Wisconsin Medical School
Madison Wisconsin, 53792, United States
Clinica Universidad de Navarra
Pamplona , 31008, Spain
Local Institution - 202
Salamanca , 37007, Spain More Info
Site 202
Contact
Universitario de Salamanca - Hospital Clinico
Salamanca , 37007, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

415

Study ID:

NCT04855136

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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