A MULTICENTER, RANDOMIZED, OPEN LABEL PHASE II STUDY OF CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE (CCyd) as pre transplant INDUCTION and post transplant consolidation or CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (CRd) as pre transplant INDUCTION and post transplant consolidation or continuous treatment with CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (12 cycles) without transplant, all followed by MAINTENANCE with LENALIDOMIDE (R) versus LENALIDOMIDE AND CARFILZOMIB (CR) IN NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS ELEGIBLE FOR AUTOLOGOUS TRANSPLANT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516630-35-01

Acronym

2024-516630-35-00

Enrollment

477

Registered

2025-01-21

Start date

2015-01-12

Completion date

Unknown

Last updated

2025-09-25

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

Conditions

NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS ELEGIBLE FOR AUTOLOGOUS TRANSPLANT

Brief summary

All patients will be included in the Intent-to-Treat (ITT) analysis. Efficacy will be assessed by considering VGPR or better (VGPR, sCR and CR) at cycle 4 in the 3 arms. Assessment of VGPR rate will be performed according to the criteria of the International Myeloma Working Group (Appendix D). To determine the progression-free survival in the 2 maintenance arms.

Detailed description

To determine the stringent complete response (sCR) rate in the 3 arms after complete induction/consolidation therapy (induction, ASCT and consolidation for the transplant arms and after 12 cycles in the long treatment arm) To determine the progression-free survival in in the 3 induction/consolidation arms.

Interventions

DRUGRevlimid 25 mg hard capsules

DRUGRevlimid 5 mg hard capsules

DRUGRevlimid 10 mg hard capsules

DRUGKyprolis 60 mg powder for solution for infusion

DRUGRevlimid 2.5 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
All patients will be included in the Intent-to-Treat (ITT) analysis. Efficacy will be assessed by considering VGPR or better (VGPR, sCR and CR) at cycle 4 in the 3 arms. Assessment of VGPR rate will be performed according to the criteria of the International Myeloma Working Group (Appendix D). To determine the progression-free survival in the 2 maintenance arms.	—

Secondary

Measure	Time frame
To determine the stringent complete response (sCR) rate in the 3 arms after complete induction/consolidation therapy (induction, ASCT and consolidation for the transplant arms and after 12 cycles in the long treatment arm) To determine the progression-free survival in in the 3 induction/consolidation arms.	—

Countries

Italy

Outcome results

None listed

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