Comparison of Pom and Dex in Subjects With RRMM Previously Treated With Len and a PI Dara/Pom/Dex vs Pom/Dex

Sponsor
Stichting European Myeloma Network
Study ID
NCT03180736
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab will be given at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs.
  • Pomalidomide — DRUG
    Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.
  • Dexamethasone — DRUG
    Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.

Study Details

The purpose of this study is to evaluate the effects of the addition of daratumumab to pomalidomide and dexamethasone in terms of progression-free survival in subjects with relapsed or refractory Multiple Myeloma.

Key Dates

Start date
Jun 14, 2017
Status verified
Dec 2024
Primary completion
Jul 21, 2020
Completion
Nov 30, 2024

Study Design

Enrollment
304 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab+Pomalidomide+Dexamethasone
    Daratumumab at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Pomalidomide 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle Dexamethasone 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle
  • Active Comparator: Pomalidomide + Dexamethasone
    Pomalidomide 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle Dexamethasone 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle

Primary Outcome Measure

Comparison of Progression Free Survival Between Treatment Arms (Daratumumab /Pomalidomide /Dexamethasone vs Pomalidomide / Dexamethasone) [ Time Frame: PFS is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 3 years). PFS2 is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 5 years). ]

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