A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Daratumumab — DRUG
  Daratumumab 16mg/kg will be administered as an intravenous (IV) infusion (into the vein) as per the following schedule: once a week during treatment cycles 1 and 2; every 2 weeks during treatment cycles 3 to 6; and every 4 weeks for cycles 7 and onwards. Following amendment 8, participants receiving daratumumab IV have the option to switch to daratumumab subcutaneous (SC) 1800 mg/dose until documented progression, unacceptable toxicity, or the end of study on Day 1 of any cycle, at the discretion of the investigator.
• Lenalidomide — DRUG
  Lenalidomide will be administered at a dose of 25 mg orally (by mouth) on Days 1 through 21 of each treatment cycle.
• Dexamethasone — DRUG
  Dexamethasone (or equivalent in accordance with local standards) will be administered as a total dose of 40 mg weekly (or 20 mg weekly for participants \> 75 years old or with a body mass index \< 18.5).

Study Details

The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.

Key Dates

Start date

Jul 23, 2014

Status verified

Apr 2025

Primary completion

Mar 7, 2016

Completion

Nov 21, 2024

Study Design

Enrollment

569 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Daratumumab + lenalidomide + dexamethasone
  During each 28-day treatment cycle, participants will receive daratumumab, lenalidomide, and dexamethasone.
• Active Comparator: Lenalidomide + dexamethasone
  During each 28-day treatment cycle, participants will receive lenalidomide and dexamethasone.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: From randomization to either disease progression or death whichever occurs first (up to 21 months) ]

Locations (23)

Find similar trials in Little Rock, AR

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