Randomized phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25578

Enrollment

420

Registered

2005-09-06

Start date

2002-08-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Multiple myeloma

Interventions

Patients will be randomized on entry between: Arm A: 8 cycles of Melphalan + Prednisone. Arm B: 8 cycles of Melphalan + Prednisone + Thalidomide. Non responders will be taken off protocol treat

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with a confirmed diagnosis of multiple myeloma stage Ib, II or III according to the Salmon & Durie criteria; 2. Age > 65 years; 3. WHO performance status 0-3; 4. Measurable tumorparameter (M-protein or Bence Jones proteïnuria); 5. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Known intolerance to Thalidomide; 2. Systemic AL amyloidosis; 3. Polyneuropathy; 4. Severe cardiac dysfunction (NYHA classification II-IV); 5. Severe pulmonary dysfunction; 6. Significant hepatic dysfunction (serum bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), unless related to myeloma; 7. Renal failure with dependency on dialysis; 8. Patients with active, uncontrolled infections; 9. Pre-treatment with cytostatic drug or alpha interferon; 10. Patients known to be HIV-positive; 11. Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma.

Design outcomes

Primary

Measure	Time frame
1. Event free survival (i.e. time from registration to induction failure, death, progression or relapse whichever occurs first); 2. Response rate (CR or PR).	—

Secondary

Measure	Time frame
1. Quality of life; 2. Toxicity of the combination therapy; 3. Overall survival measured from time of registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive; 4. Progression free survival measured from the time of achievement of PR (or CR) to date of relapse, progression or death from any cause (whichever occurs first).	—

Contacts

Public ContactP.W. Wijermans

Haga Hospital, location Leyenburg Hospital, Department of Hematology, P.O. Box 40551

p.wijermans@hagaziekenhuis.nl+31 (0)70 3592556

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)