Myelo-ablative chemo/radiotherapy and autologous stem cell transplantation as compared to only chemotherapy in patients with multiple myeloma

Completed

• Conditions: Multiple Myeloma; Cancer

• Registration Number: ISRCTN82155239
• 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: 452

Inclusion Criteria

At entry:
1. Previously untreated multiple myeloma, stage 2 or 3 according to Salmon and Durie
2. Aged less than 66 years
3. World Health Organization (WHO) performance status 0 - 3
4. Informed consent

For Interferon (IFN) maintenance and Peripheral Blood Stem Cell Transplant (PBSCT) or Allogeneic Bone Marrow Transplant (ABMT):
1. At least Partial Remission (PR) after induction therapy
2. WHO performance status 0 - 2
3. Suitable peripheral stem or bone marrow graft
4. No active infections
5. Absence of severe cardiac, pulmonary, neurologic, psychiatric disease
6. Serum creatinine, bilirubin and transaminases of less than 2.5 x upper limit of normal values
7. Platelet count greater than 50 x 10^9/l
8. Absolute neutrophil count greater than 1 x 10^9/l
9. Informed consent

Exclusion Criteria

At entry:
1. Received more than 2 courses of melphalan, prednisone or vincristine, melphalan (M), cyclophosphamide, prednisone (VMCP)
2. Severe cardiac disease (= severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45% with presence of normal hemoglobin), severe pulmonary, neurologic or metabolic disease- Inadequate liver function, i.e., bilirubin greater than or equal to 25 x upper normal value
3. Prior malignancies except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
4. Prior extensive radiotherapy involving the myelum (precluding total body irradiation)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission rate.

Secondary Outcome Measures

Name	Time	Method
1. Event-free survival<br>2. Overall survival<br>3. Quality of life<br>4. Cost-benefit