Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nordic Myeloma Study Group
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Melphalan; Thalidomide

Criteria

Inclusion Criteria:

• Treatment demanding multiple myeloma

• Refractoriness to melphalan

• Acceptance of rules for prevention of pregnancy

Exclusion Criteria:

• Previous treatment with bortezomib, thalidomide, or lenalidomide

• Sensory neuropathy grade III or neuropathic pain grade II

• Severe concomitant disorder, e.g. other malignancy or severe heart disease

• Transformation to plasma cell leukemia or aggressive lymphoma

• Frequent visits for bortezomib injections not feasible

• Anticipated non-adherence to study protocol

• Pregnancy

• Anticipated non-adherence to rules for prevention of pregnancy

• Severe thrombocytopenia (Thrombocyte count less than 25000/microliter)