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Cyclophosphamide, Lenalidomide and Dexamethasone (CRD) Versus Melphalan (200 mg/m2) Followed By Autologous Stem Cell Transplant (ASCT) In Newly Diagnosed Multiple Myeloma Subjects

NCT01091831 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2024-11-06

No results posted yet for this study

Summary

This is a multicenter, randomized, open label study designed to compare the efficacy and safety of lenalidomide with low-dose alkylating agents versus high-dose melphalan followed by stem cell support in newly diagnosed symptomatic MM patients who are 65 years of age or younger.

Conditions

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide will be given orally at the dose of 300 mg/m2 on days 1, 8, 15 for 6 cycles every 28 days

DRUG

Lenalidomide

Lenalidomide will be given orally at the dose of 25 mg/d for 21 days followed by a 7 days rest period (day 22 to 28)for 6 cycles every 28 days

DRUG

Dexamethasone

Dexamethasone will be given orally at the dose of 40 mg on days 1, 8, 15, 22 for 6 cycles every 28 days

DRUG

Melphalan

Melphalan will be given iv at the dose of 200 mg/m2 for 1 day followed by stem cell support. The second MEL200 was performed 120 days after the first if ≤ PR was achieved after the 1st MEL200.

Sponsors & Collaborators

  • Fondazione EMN Italy Onlus

    lead OTHER

Principal Investigators

  • Francesca Gay, MD · Division of Hematology - University of Torino - A.O.U. Città della Salute e della Scienza di Torino - Torino - Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2021-09-30
Completion
2024-07-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01091831 on ClinicalTrials.gov