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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509848-10-00

Acronym

BB2121-MM-003

Enrollment

138

Registered

2024-06-10

Start date

2019-06-12

Completion date

Unknown

Last updated

2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma (MM) with at least 2 prior therapies including an immunomodulatory (IMiD) compound and a proteasome inhibitor (PI) and demonstrated disease progression on or within 60 days of completion of the last therapy.

Brief summary

Progression-free survival (PFS)

Detailed description

Overall Response Rate (ORR), Overall Survival (OS), Event-free Survival (EFS), Minimal Residual Disease (MRD), Complete Response (CR) Rate, Duration of Response (DOR), Time to Response (TTR), Safety, Pharmacokinetics (PK) – bb2121, Primary Domains of Interest Health Related Quality of Life (HRQoL), Time to next anti-myeloma treatment, Progression-free survival after next line therapy (PFS2)

Interventions

DRUGIXAZOMIB

DRUGRevlimid 5 mg hard capsules

DRUGImnovid 4 mg hard capsules

DRUGDexamethason CF 20 mg/ml

DRUGinjectievloeistof

DRUGidecabtagene vicleucel

DRUGImnovid 1 mg hard capsules

DRUGRevlimid 10 mg hard capsules

DRUGRevlimid 25 mg hard capsules

DRUGImnovid 2 mg hard capsules

DRUGDexamethasone Tablets BP 2.0mg

DRUGImnovid 3 mg hard capsules

DRUGDexamethason 4 mg JENAPHARM®

DRUGVELCADE 3.5 mg powder for solution for injection

DRUGRevlimid 15 mg hard capsules

DRUGDARZALEX 20 mg/mL concentrate for solution for infusion

DRUGELOTUZUMAB

DRUGKyprolis 30 mg powder for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	—

Secondary

Measure	Time frame
Overall Response Rate (ORR), Overall Survival (OS), Event-free Survival (EFS), Minimal Residual Disease (MRD), Complete Response (CR) Rate, Duration of Response (DOR), Time to Response (TTR), Safety, Pharmacokinetics (PK) – bb2121, Primary Domains of Interest Health Related Quality of Life (HRQoL), Time to next anti-myeloma treatment, Progression-free survival after next line therapy (PFS2)	—

Countries

Belgium, France, Germany, Italy, Netherlands, Norway, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026