Overview

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)