Treatment for Elderly Fit Newly Diagnosed Multiple Myeloma Patients Aged Between 65 and 80 Years

Sponsor
PETHEMA Foundation
Study ID
NCT03742297
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Newly Diagnosed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
65 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide. — DRUG
    Lenalidomide
  • Carfilzomib — DRUG
    Carfilzomib
  • Bortezomib — DRUG
    Bortezomib
  • Daratumumab — DRUG
    Daratumumab
  • Dexamethasone — DRUG
    Dexamethasone
  • Prednisone — DRUG
    Prednisone
  • Melphalan — DRUG
    Melphalan

Study Details

The study is designed as a randomized, controlled, open-label, assessor blind, multicenter superiority trial with three parallel groups, and primary endpoint of immunophenotypic complete responses at 18 months after randomization. Block randomization will be performed with a 1:1:1 allocation ratio. Patients will be randomized up front to 3 arms. Patients will receive "standard" PETHEMA arm for fit elderly VMP x 9 + Rd x 9 (arm 1, control arm), a KRd regimen (arm 2a) (18 cycles) or a Carfilzomib-lenalidomida-dexametasona regimen combined with DARATUMUMAB (arm 2b) (18 cycles).

Key Dates

Start date
Oct 22, 2018
Status verified
Sep 2022
Primary completion
Jul 31, 2023
Completion
Jan 31, 2031

Study Design

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

Arms

  • Active Comparator: VMP x 9 + Lenalidomida-dexamethasone x 9
    Bortezomib-melfalán-prednisone. Melfalán: 9mg/m2D1-4. Prednisone: 60mg/m2D1-4. Bortezomib: 1.3mg/m2 One 6 week cycleD1, 4, 8, 11, 22, 25, 29 and 32; followed by eight4-week cycleD1, 8, 15 and 22 Lenalidomida-dexametasona at low dose
  • Experimental: Carfilzomib-lenalidomida-dexamethasone regimen
    carfilzomib: 1 st cycle: 20mg/m2 day 1 and 36 mg/m2 days 2, 8, 9 \& 15, 16. 2nd cycle: 36 mg/m2 days 1, 2, 8, 9 \& 15, 16. Cycles 3-18: 56 mg/m2 days 1, 8 \& 15.Lenalidomida: 25 mg, d1-21 Dexamethasone : 40 mg, d1, 8, 15, 2218 28-day cycle
  • Experimental: Carfilzomib-lenalidomida-dexamethason with daratumumab
    Carfilzomib: 1 st cycle: 20mg/m2 day 1 and 36 mg/m2 days 2, 8, 9 \& 15, 16. 2nd cycle: 36 mg/m2 days 1, 2, 8, 9 \& 15, 16. Cycles 3-18: 56 mg/m2 days 1, 8 \& 15. Lenalidomida: 25 mg, d1-21 Dexamethasone: 40 mg, d1, 8, 15, 22. Daratumumab 1800mg SC Days 1, 8, 15, 22 of cycles 1-2; Days 1 and 15 of cycles 3 and 4; Day 1 of cycles 5 to 18

Primary Outcome Measure

Efficacy in terms of numbers of compleat responses [ Time Frame: 18 months ]

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