Multiple Myeloma
Conditions
Keywords
Multiple myeloma, Elderly patients, Thalidomide, Autologous transplantation
Brief summary
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.
Detailed description
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.
Interventions
DRUGThalidomide
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Best response rate | — |
| Progression-free survival | — |
| Survival after progression | — |
| Toxicity | — |
Countries
France
Outcome results
None listed