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

Completed

• Conditions: Multiple Myeloma; Cancer; Multiple myeloma and malignant plasma cell neoplasms

• Registration Number: ISRCTN90692740
• Lead Sponsor: Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 420

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

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 =25 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Event free survival (i.e. time from registration to induction failure, death, progression or relapse whichever occurs first)<br>2. Response rate (complete response [CR] or partial response [PR])

Secondary Outcome Measures

Name	Time	Method
1. Quality of life<br>2. Toxicity of the combination therapy<br>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.<br>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)