Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM

Conditions

• Myeloma, Multiple

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Lenalidomide — DRUG
  Induction and Maintenance
• Ixazomib — DRUG
  Induction and Only Maintenance Arm B
• Daratumumab Injection — DRUG
  Induction and Only Maintenance Arm B
• Dexamethasone — DRUG
  Induction and Only Maintenance Arm B

Study Details

A randomized Phase II clinical trial will be conducted to assess the impact on progression free survival (PFS) with the addition of ixazomib and daratumumab to lenalidomide as a maintenance treatment following induction with lenalidomide, ixazomib, dexamethasone, and daratumumab. Patients will be randomized to either: Arm A: 12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone followed by lenalidomide until disease progression or unacceptable toxicity or a maximum of 2 years of maintenance therapy. Arm B: 12 cycles of lenalidomide, ixazomib, daratumumab and dexamethasone, followed by lenalidomide, ixazomib, and daratumumab until disease progression or unacceptable toxicity or a maximum of 2 years maintenance therapy.

Key Dates

Start date

Oct 21, 2020

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

79 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lenalidomide
  12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone followed by lenalidomide until disease progression or unacceptable toxicity or a maximum of 2 years of maintenance therapy.
• Experimental: Lenalidomide, Ixazomib, Daratumumab, and Dexamethasone
  12 cycles of lenalidomide, ixazomib, dexamethasone, and daratumumab followed by lenalidomide, ixazomib, and daratumumab until disease progression or unacceptable toxicity or a maximum of 2 year maintenance therapy.

Primary Outcome Measure

Impact of Study Treatment on Progression Free Survival (PFS) [ Time Frame: 5 Years ]

Locations (7)

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