Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma

University Hospital, Lille500 enrolled

Overview

In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.

Trial design This multicenter, randomized, controlled trial is conducted by the French Myeloma Intergroup(IFM) in elderly patients with previously untreated multiple myeloma. The primary objectives of the study are to compare the efficacy and safety of MP with MP-Thalidomide or with MEL100 (intermediate-dose melphalan 100 mg/m2 - based treatment). The secondary objective is to compare the efficacy of MP-Thalidomide vs MEL100.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Multiple Myeloma

Interventions

ThalidomideDRUG

Eligibility

Sex: ALLMin age: 65 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stage II or III multiple myeloma according to Durie and Salmon criteria. * Patients between 65 and 75 years of age * Previously untreated patients Exclusion Criteria: * Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma) * Primary or associated amyloidosis * World Health organisation performance index of at least 3 * Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more * Cardiac or hepatic dysfunction * Cerebral circulatory insufficiency * Absolute contraindication to corticosteroids * Peripheral neuropathy * HIV or hepatitis B or C positivity * Patients who had geographic, social or psychological conditions which might prevent adequate follow-up

Locations (1)

Lille University Hospital

Lille, France

Outcomes

Primary Outcomes

Overall survival

Secondary Outcomes

Best response rate

Progression-free survival

Survival after progression

Toxicity

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.