A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.

Summary

The purpose of this study is to determine whether lenalidomide is safe and effective in the treatment of patients with newly diagnosed Multiple Myeloma who are 65 years of age or older.

Conditions

• Newly Diagnosed Multiple Myeloma

Interventions

DRUG

Lenalidomide: Double-blind Induction

Double-blind Induction: the starting lenalidomide oral dosing regimen was 10 mg once daily on Days 1 through 21 of each 28 day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

DRUG

Melphalan

Double-blind Induction: the starting melphalan oral dosing regimen in all 3 treatment arms was 0.18 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

DRUG

Prednisone

Double-blind induction: the starting prednisone oral dosing regimen in all 3 treatment arms was 2 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

DRUG

Aspirin

Double-blind induction: low-dose aspirin 75 mg to 100 mg daily for all treatment arms. Double-blind maintenance: at the investigator's discretion

DRUG

Placebo

Double-blind induction: participants in treatment arm MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle for up to 9 cycles. Double-blind maintenance: participants in treatment arms MPR+p and MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.

DRUG

Lenalidomide: Double-blind Maintenance

Single-agent oral lenalidomide 10 mg once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.

DRUG

Lenalidomide: Open-label

Any study participant who had progressive disease had the option of open-label lenalidomide up to 25 mg daily on Days 1 through 21 of each 28-day cycle.

Sponsors & Collaborators

• Celgene Corporation

  lead INDUSTRY

Principal Investigators

• Antonio Palumbo, M.D. · Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2009-11-30

Completion

2016-04-30

Countries

• Australia
• Austria
• Belarus
• Belgium
• Czechia
• Denmark
• France
• Georgia
• Germany
• Greece
• Ireland
• Israel
• Italy
• Netherlands
• Poland
• Russia
• Spain
• Sweden
• Switzerland
• Turkey (Türkiye)
• Ukraine
• United Kingdom

Study Locations