Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00644306

Acronym

IFM 01/01

Enrollment

232

Registered

2008-03-26

Start date

2002-04-30

Completion date

2007-05-31

Last updated

2008-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed, Multiple Myeloma

Keywords

Multiple Myeloma, very elderly patients, thalidomide

Brief summary

In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.

Interventions

DRUGThalidomide

100 mg/day continuously for 18 months

DRUGmelphalan, prednisone

12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months

DRUGmelphalan, prednisone, thalidomide

12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

75 Years to No maximum

Healthy volunteers

Inclusion criteria

* Stage II or III multiple myeloma according to Durie and Salmon criteria, patients older than 75 years, previously untreated patients.

Exclusion criteria

* Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma) * Primary or associated amyloïdosis * 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 clinically significant * History of venous thrombosis during the last 6 months * HIV or hepatitis B or C positivity * Patients who had geography, social, or psychological conditions which might prevent adequate follow-up.

Design outcomes

Primary

Measure	Time frame
overall Survival	May 2007

Secondary

Measure	Time frame
Progression Free Survival	May 2007
Response rates	May 2007
Safety	May 2007

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026