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Lenalidomide and Dexamethasone Versus Melphalan Prednisone and Lenalidomide Versus Cyclophosphamide, Prednisone and Lenalidomide in Elderly Multiple Myeloma Patients

NCT01093196 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2024-11-07

No results posted yet for this study

Summary

This is a multicenter, randomized, controlled, 3 arm parallel group study designed to evaluate the efficacy and safety of three all-oral combinations: lenalidomide with dexamethasone (Rd) in comparison with lenalidomide in association with MP (MPR) and lenalidomide in association with cyclophosphamide - prednisone (CPR) in newly diagnosed symptomatic MM patients. This protocol also provides a substudy designed to observe asymptomatic patients excluded to the protocol that in any case could be inserted in the study.

Conditions

Interventions

DRUG

Melphalan, Prednisone, Lenalidomide

Induction: 9 courses every 28 days - oral Lenalidomide for 21 days followed by a 7 days rest period; oral Melphalan for 4 days, followed by a 24 days rest period \[different doses according to the age of patients (65-75 or \>75 years old);oral Prednisone for 4 days followed by a 24 day rest period. Maintenance: ARM A1, B1 and C1 - oral Lenalidomide on day 1-21 followed by a 7 days rest period. ARM A2,B2 and C2:oral Lenalidomide on day 1-21 followed by a 7 days rest period and oral Prednisone every other day.Each cycle will be repeated every 28 days, until any sign of disease progression(PD).

DRUG

Cyclophosphamide, Prednisone, Lenalidomide

Induction: 9 cycles every 28 days:Lenalidomide will be given orally at the dose of 25 mg/day for 21 days followed by a 7 days rest period (day 22 to 28;Cyclophosphamide will be given orally at the dose of 50 mg /day for 21 days followed by a 7 day rest period (days 1 to 28) in patients 65-75 years old and 50 mg every other day (days 1 to 20 followed by a 8 days rest period \[day 21 to 28\]) in patients older than 75 years.Prednisone will be given orally at the dose of 25 mg every other day (days 1 to 28.Each cycle will be repeated every 28 days, until any sign of disease progression(PD).

DRUG

Lenalidomide, dexamethasone

Induction: 9 course every 28 days-Lenalidomide will be given orally at the dose of 25 mg/day for 21 days followed by a 7 days rest period (day 22 to 28); Dexamethasone will be given orally at the dose of 40 mg on days 1, 8, 15 and 22 every 28 days in patients 65-75 years old and at the dose of 20 mg on days 1,8,15 and 22 every 28 days in patients older than 75 years. Maintenance:After 2-3 months from the completion of the last induction cycle, patients will start maintenance therapy according to physician willing and general dose-reduction rules.ARM A1, B1 and C1:Lenalidomide will be given at the dose of 10 mg/day on day 1-21 followed by a 7 days rest period. ARM A2, B2 and C2:Lenalidomide will be given at the dose of 10 mg/day on day 1-21 followed by a 7 days rest period; Prednisone will be given orally at the dose of 25 mg every other day (days 1 to 28) Each cycle will be repeated every 28 days, until any sign of disease progression (PD).

Sponsors & Collaborators

  • Fondazione EMN Italy Onlus

    lead OTHER

Principal Investigators

  • Mario Boccadoro, MD · Fondazione EMN Italy Onlus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-11-30
Completion
2024-07-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

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 NCT01093196 on ClinicalTrials.gov