Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). It is not yet known whether chemotherapy followed by peripheral blood stem cell transplant is more effective with or without thalidomide in treating multiple myeloma.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with thalidomide to see how well it works compared with giving combination chemotherapy without thalidomide in treating patients with multiple myeloma.

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

Details

• Lead Sponsor: Commissie Voor Klinisch Toegepast Onderzoek
• Treatments: BB 1101; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Interferon-alpha; Interferons; Liposomal doxorubicin; Melphalan; Thalidomide; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed multiple myeloma

• Stage II or III

• No systemic amyloid light-chain amyloidosis

PATIENT CHARACTERISTICS:

Age:

• 18 to 65

Performance status:

• WHO 0-3

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• No significant hepatic dysfunction*

• Bilirubin less than 1.75 mg/dL*

• AST/ALT less than 2.5 times normal* NOTE: *Unless related to myeloma

Renal:

• Not specified

Cardiovascular:

• No severe cardiac dysfunction

• No New York Heart Association class II, III, or IV heart disease

Other:

• HIV negative

• No active uncontrolled infection

• No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

• No known intolerance to thalidomide

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Patients 18 to 55 years of age must not have been allocated before study randomization to allogeneic stem cell transplantation with an HLA-identical sibling donor

Chemotherapy:

• No more than 2 prior courses of melphalan and prednisone therapy for local myeloma progression

• No other prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Prior local radiotherapy for local myeloma progression allowed

• No other prior radiotherapy

Surgery:

• Not specified