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Revlimid And Prednisone Followed By Revlimid, Melphalan And Prednisone In Multiple Myeloma Patients

NCT01160107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-06-29

No results posted yet for this study

Summary

This study will determine whether the association of Revlimid and Prednisone (RP) as induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation treatment is safe and induce a significant rate of PR (and CR) in newly diagnosed elderly MM patients.

Conditions

Interventions

DRUG

RP followed by MPR

Induction (4 cycles):Lenalidomide 25 mg/die for 21 days followed by a 7 days rest period and Prednisone at 50 mg three times a week continuously . Consolidation (6 cycles): Melphalan 2 mg three times a week, Prednisone 50 mg three times a week, and Lenalidomide 15 mg/die for 21 days followed by a 7 days rest period. According to the results of the first stage the decisions are as follows: 1. Starting a second stage, at the same dose of lenalidomide for MPR cycles, if grade 3-4 adverse events are 25-50% and PR \> 50%; 2. The study stop (if PR \<40% and grade 3-4 adverse events \>25-30%) 3. A new first stage may be started: - Lenalidomide 20 mg/die if grade 3-4 adverse events are \< 25-30%, independently from efficacy; - Lenalidomide 10 mg/die if grade 3-4 adverse events are \> 50% and PR rate \> 50%. Maintenance: Lenalidomide 10 mg/day from day 1 to 21, followed by a 7-day rest period and Prednisone 25 mg three times a week.Each cycle will be repeated every 28 days, until PD.

Sponsors & Collaborators

  • Fondazione EMN Italy Onlus

    lead OTHER

Principal Investigators

  • Mario Boccadoro, MD · S.C. Ematologia U - AOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-08-31
Completion
2022-12-22

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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 NCT01160107 on ClinicalTrials.gov