Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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
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.
Enrollment
Sex
Ages
Volunteers
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:
Participant has received:
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.
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:
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.
Primary purpose
Allocation
Interventional model
Masking
312 participants in 2 patient groups
Loading...
Central trial contact
BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain NCT # and Site #.
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal