Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Austrian Forum Against Cancer
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Melphalan; Prednisone; Thalidomide

Criteria

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