Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma (NCT04855136) | Clinical Trial Compass
TerminatedPhase 1
Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma
Stopped: Business objectives have changed
United States, Spain21 participantsStarted 2021-06-01
Plain-language 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)
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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
Exclusion criteria
. ANC and Platelets count as reported below
. Hemoglobin \< 8 g/dL (\< 4.9 mmol/L) (transfusion is not permitted within 21 days of screening)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Does Limiting Toxicity (DLT) rates _Phase 1
Timeframe: Up to 28 days from start of the combination therapy
. 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)