Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, first line treatment, thalidomide, melphalan
Brief summary
This is an international multi-center prospective, double randomized, open, controlled phase III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients.
Interventions
DRUGThalidomide/Dexamethasone vs Melphalan/Prednisone
Sponsors
Austrian Forum Against Cancer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light chain, low secretory or non-secretory disease * WHO performance status 0,1,2,or 3 * No prior treatment of multiple myeloma * Clear requirement of treatment (usually Durie/Salmon stage II or III) * Anticipated life expectancy of at least 3 months * Adequate organ function * Minimum recovery period of 2 weeks following any major surgical procedure before entry into this study * Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal * Age of at least 19 years, there is no upper age limit patients must have been informed and must have signed an informed consent
Exclusion criteria
* Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease * Benign monoclonal gammopathy * Multiple myeloma of IgM without osteolytic bone lesions * Smouldering myeloma * More than 3 irradiation fields * Irreversible performance status of WHO4 * Prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs * Women of childbearing potential * Preexisting peripheral polyneuropathy * Congestive heart failure NYHA III, IV * Acute infection requiring systemic antibiotics at study entry until resolved * Any uncontrolled underlying medical condition (eg diabetes, glaucoma) * Second primary malignancy (with the exception of cervical carcinoma in situ and non-myeloma skin malignancies) unless patient has been disease-free for at least three years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | — |
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival | — |
| Time to response | — |
| Toxicity | — |
| Quality of life | — |
Countries
Austria
Outcome results
None listed