Multiple myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: Velcade
Pharmaceutical Form: Injection*
Product Name: Thalidomide
Pharmaceutical Form: Tablet
Sponsors
Nordic Myeloma Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Treatment demanding multiple myeloma 2) Melphalan refractoriness defined by disease progress during melphalan therapy or early relapse after high dose melphalan therapy or oral melphalan-prednisone therapy 3) Women with childbearing potential shall have performed a pregnancy test with negative result and are obliged to use efficacious contraceptives. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous therapy with bortezomib, thalidomide or lenalidomide 2. Sensory neuropathy grade III or neuropahtic pain grade II according to CTC criteria 3. Other severe disease, e.g. other active neoplasia or severe heart disease 4. Myeloma disease transformation to plasma cell leukaemia or high grade B cell lymphoma 5. Frequent visits for Velcade injections not feasible 6. Presumed poor adherence to protocol expected because of pychiatric disease, abuse, etc. 7. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison between Velcade and thalidomide with respect to progression free survival in patients whith melphalan refractory multiple myeloma;Secondary Objective: Response rate, response duration, time to other treatment, toxicity and quality of life;Primary end point(s): Progression free survival | — |
Countries
Denmark, Sweden
Outcome results
None listed