A phase II multicenter study of carfilzomib, lenalidomide and dexamethasone (KRd) as induction therapy, followed by high-dose therapy with melphalan and autologous peripheral blood stem cell transplantation, consolidation with KRd, and maintenance with lenalidomide and dexamethasone in patients ≤ 70 years old with smoldering multiple myeloma (SMM) with high risk of progression to symptomatic myeloma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516908-42-00

Enrollment

Registered

2024-10-23

Start date

2015-06-15

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Smoldering multiple myeloma with high risk of progression to symptomatic myeloma

Brief summary

• Immunophenotypic complete remission (CR by flow cytometry) day +100 after induction treatment and HDT-ASCT.

Detailed description

• Immunophenotypic complete remission (CR by flow cytometry), after consolidation and maintenance, and at 3 and 5 years post-HDT-ASCT., • Response rates (sCR, CR, VGPR and ORR) after the different phases of treatment (induction, HDT-ASCT, consolidation, maintenance and rescue therapy)., • TTP to symptomatic disease, PFS and OS., • Safety profile after the different phases of treatment: induction, high-dose melphalan treatment and autologous hematopoietic stem cell transplantation, consolidation, maintenance and rescue therapy.

Interventions

DRUGDEXAMETHASONE

DRUGImnovid 2 mg hard capsules

DRUGImnovid 1 mg hard capsules

DRUGDARATUMUMAB

DRUGImnovid 3 mg hard capsules

DRUGImnovid 4 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Immunophenotypic complete remission (CR by flow cytometry) day +100 after induction treatment and HDT-ASCT.	—

Secondary

Measure	Time frame
• Immunophenotypic complete remission (CR by flow cytometry), after consolidation and maintenance, and at 3 and 5 years post-HDT-ASCT., • Response rates (sCR, CR, VGPR and ORR) after the different phases of treatment (induction, HDT-ASCT, consolidation, maintenance and rescue therapy)., • TTP to symptomatic disease, PFS and OS., • Safety profile after the different phases of treatment: induction, high-dose melphalan treatment and autologous hematopoietic stem cell transplantation, consolidation, maintenance and rescue therapy.	—

Measure

Time frame

—

Countries

Spain

Outcome results

None listed

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