A randomised phase III study on the effect of bortezomib combined with adriamycin, dexamethasone (AD) for induction treatment, followed by high dose melphalan and bortezomib alone during maintenance in patients with multiple myeloma

Completed

• Conditions: Multiple myeloma; Cancer

• Registration Number: ISRCTN64455289
• Lead Sponsor: Dutch Haemato-oncology Association (Stichting Haemato-Oncologie voor Volwassenen Nederland [HOVON])

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 800

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 (WHO = three is allowed only when caused by multiple myeloma and not by co-morbid conditions)
4. Negative pregnancy test at inclusion if applicable
5. Written informed consent

Exclusion Criteria

1. Known intolerance of thalidomide or boron
2. Systemic AL amyloidosis
3. Non-secretory multiple myeloma
4. Previous chemotherapy or radiotherapy except two cycles of melphalan/prednisone or local radiotherapy in case of local myeloma progression
5. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II - IV)
6. Significant hepatic dysfunction (serum bilirubin more than or equal to 30 µmol/l or transaminases more than or equal to 2.5 times normal level), unless related to myeloma
7. Patients known to be Human Immunodeficiency Virus (HIV) positive
8. Patients with active, uncontrolled infections
9. Patients with neuropathy, CTC grade two or higher
10. Patients with a history of active malignancy during the past five years with the exception of basal carcinoma of the skin or stage zero cervical carcinoma
11. Patients who will not give permission for collection of Bone Marrow (BM) aspirate at entry
12. Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women)
13. Patients 65 years or less with a Human Leukocyte Antigen (HLA) identical sibling who will undergo non-myeloablative AlloSCT
14. Lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS), i.e. time from registration to progression, relapse or death from any cause.

Secondary Outcome Measures

Name	Time	Method
1. Response (Partial Remission [PR], very Good Partial Remission [vGPR] and Complete Remission [CR])<br>2. Overall Survival (OS)<br>3. PFS from High-Dose Therapy (HDT) i.e. time from last High-Dose Melphalan (HDM) treatment to progression, relapse or death from any cause whichever occurs first for patients who received at least PR on HDT<br>4. Toxicity<br>5. PFS analysed as primary endpoint, but patients with an allogeneic transplant not censored. This primarily to check whether censoring has a major impact.