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

NCT03742297 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2022-09-14

No results posted yet for this study

Summary

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).

Conditions

  • Newly Diagnosed Multiple Myeloma

Interventions

DRUG

Lenalidomide.

Lenalidomide

DRUG

Carfilzomib

Carfilzomib

DRUG

Bortezomib

Bortezomib

DRUG

Daratumumab

Daratumumab

DRUG

Dexamethasone

Dexamethasone

DRUG

Prednisone

Prednisone

DRUG

Melphalan

Melphalan

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Jesús F San Miguel · Clínica Universidad de Navarra

  • Joan Blade, Dr · Hospital Clinic of Barcelona

  • Juan Jose Lahuerta, Dr · Hospital 12 de Octubre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2023-07-31
Completion
2031-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03742297 on ClinicalTrials.gov