A Randomized, Open-label Phase 3 Study of Carfilzomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone (KRd vs. VRd) in Patients With Newly Diagnosed Multiple Myeloma (COBRA)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518473-34-00

Acronym

PMC010

Enrollment

233

Registered

2024-12-11

Start date

2019-11-20

Completion date

Unknown

Last updated

2025-04-02

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

Conditions

Multiple Myeloma

Brief summary

The MRD-negative complete response status at 12 months by NGS and PFS defined as the time to progressive disease or death as defined by IMWG criteria

Detailed description

The MRD-negative status in each study arm at 8and 24 months, Duration of MRD-negative status., MRD-negative complete response, Comparing rate of PR or better, VGPR or better, CR or better, or sCR at 8, 12, 24, 36, 48, and 60 months and as best response between the two arms, Determine rates of improvement of the depth of response by at least one category according to IMWG response criteria. (For example, an improvement from very good partial response (VGPR) to near complete response (nCR) or better than nCR including conversion from CR to MRD negative disease [overall response]) at specified landmark timepoints., To compare overall survival., Safety and tolerability of KRd vs. VRd

Interventions

DRUGRevlimid 20 mg hard capsules

DRUGRevlimid 10 mg hard capsules

DRUGRevlimid 15 mg hard capsules

DRUGRevlimid 25 mg hard capsules

DRUGKyprolis 60 mg powder for solution for infusion

DRUGRevlimid 5 mg hard capsules

DRUGVELCADE 3.5 mg powder for solution for injection

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The MRD-negative complete response status at 12 months by NGS and PFS defined as the time to progressive disease or death as defined by IMWG criteria	—

Secondary

Measure	Time frame
The MRD-negative status in each study arm at 8and 24 months, Duration of MRD-negative status., MRD-negative complete response, Comparing rate of PR or better, VGPR or better, CR or better, or sCR at 8, 12, 24, 36, 48, and 60 months and as best response between the two arms, Determine rates of improvement of the depth of response by at least one category according to IMWG response criteria. (For example, an improvement from very good partial response (VGPR) to near complete response (nCR) or better than nCR including conversion from CR to MRD negative disease [overall response]) at specified landmark timepoints., To compare overall survival., Safety and tolerability of KRd vs. VRd	—

Measure

Time frame

—

Countries

Finland, Norway, Poland

Outcome results

None listed

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