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

Sponsor

Austrian Forum Against Cancer (Other)

Overall Status

Completed

CT.gov ID

NCT00205751

Collaborator

(none)

350

Enrollment

Location

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Thalidomide/Dexamethasone vs Melphalan/Prednisone	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma

Study Start Date :

Aug 1, 2001

Actual Study Completion Date :

Oct 1, 2009

Outcome Measures

Primary Outcome Measures

Time to progression []
Response rate []

Secondary Outcome Measures

Survival []
Time to response []
Toxicity []
Quality of life []

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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