CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 386 enrolled / 386 target
Drug / intervention
bb2121 +8 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03651128
NCT03651128Phase 3CompletedMonitor (4.5/mo)Completion was 2mo ago
CompareCT.gov

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)

Celgene·interventional·Posted Aug 29, 2018·Updated Jun 22, 2026

In Brief

A Phase 3 clinical trial evaluating bb2121, Daratumumab, and 7 other interventions for Multiple Myeloma. Completed, enrolled 386 participants across 62 sites in 13 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesBelgium, Canada, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 29, 2018
Enrollment StartApr 16, 2019
Primary CompletionApr 13, 2026
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 7.8 years ago

Arms & Interventions

Arm A - Administration of bb2121experimental

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
Arm B- standard regimens as per Investigator's discretionexperimental

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: DaratumumabDrug: PomalidomideDrug: DexamethasoneDrug: BortezomibDrug: IxazomibDrug: LenalidomideDrug: CarfilzomibDrug: Elotuzumab

Interventions

bb2121biological

bb2121

Daratumumabdrug

Daratumumab

Pomalidomidedrug

Pomalidomide

Dexamethasonedrug

Dexamethasone

Bortezomibdrug

Bortezomib

Ixazomibdrug

Ixazomib

Lenalidomidedrug

Lenalidomide

Carfilzomibdrug

Carfilzomib

Elotuzumabdrug

Elotuzumab