A randomised phase III study on the effect of thalidomide combined with Adriamycin®, dexamethasone and high dose melphalan in patients with multiple myeloma

Phase 3

Completed

Conditions: Multiple myeloma
Cancer
Multiple myeloma and malignant plasma cell neoplasms

Registration Number: ISRCTN06413384

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 450

Inclusion Criteria

1. Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon and Durie criteria
2. Age 18 to 65 years inclusive
3. World Health Organisation (WHO) performance status zero to three
4. Negative pregnancy test at inclusion if applicable
5. Written informed consent

Exclusion Criteria

1. Known intolerance to thalidomide
2. Systemic AL amyloidosis
3. Previous chemotherapy or radiotherapy except two cycles of melphalan/prednisone or local radiotherapy in case of local myeloma progression
4. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II to IV)
5. Significant hepatic dysfunction (serum bilirubin greater than or equal to 30 micromol/l or transaminases greater than or equal to 25 times normal level), unless related to myeloma
6. Patients known to be Human Immunodeficiency Virus (HIV)-positive
7. Patients with active, uncontrolled infections
8. Patients with a history of active malignancy during the past five years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
9. Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women)
10. Patients less than or equal to 55 years with a Human Leukocyte Antigen (HLA)-identical sibling who will undergo myeloablative Allogeneic Stem Cell Transplantation (AlloSCT)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival (i.e. time from registration to induction failure, progression or death, whichever occurs first); the time to failure of patients with induction failure is set at one day. Patients are considered induction failure when they have not achieved at least a Partial response (PR) and are not eligible for further treatment according to protocol.

Secondary Outcome Measures

Name	Time	Method
1. Response (PR and Complete Response [CR])<br>2. Overall survival measured form the time of registration. Patient still alive or lost to follow up are censored at the date they were last known to be alive<br>3. Progression free survival (duration of the first response [PR or CR]) measured from the time of achievement of PR (or CR) to date of progression or death from any cause (whichever occurs first)<br>4. Toxicities of thalidomide and chemotherapy