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

Austrian Forum Against Cancer

Status and phase

Completed

Phase 3

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Thalidomide/Dexamethasone vs Melphalan/Prednisone

Study type

Interventional

Funder types

Other

Identifiers

NCT00205751

01-002-0601

Details and patient eligibility

About

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.

Enrollment

350 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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