Chemotherapy and Peripheral Stem Cell Transplantation Followed By Immunotherapy in Treating Patients With Multiple Myeloma

• Status: Completed
• Trial end date: 2008-02-01
• 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. Combining chemotherapy with autologous peripheral stem cell transplantation and immunotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Randomized phase I/II trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation followed by immunotherapy in treating patients who have multiple myeloma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: University of Maryland Greenebaum Cancer Center
• Treatments: Carmustine; Cyclophosphamide; Heptavalent Pneumococcal Conjugate Vaccine; Melphalan; Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma requiring systemic treatment

• No obvious myelodysplastic changes in the marrow

PATIENT CHARACTERISTICS:

Age

• 18 to 80

Performance status

• ECOG 0-2 (ECOG 3-4 allowed if based solely on bone pain)

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No chronic active hepatitis

• No liver cirrhosis

Renal

• Creatinine no greater than 3.0 mg/dL

• No dialysis

Cardiovascular

• LVEF at least 45% unless no evidence of untreated clinically significant functional impairment

Pulmonary

• FEV_1 and FVC at least 50% of predicted

• Total lung capacity at least 50% of predicted

• DLCO at least 50% of predicted

• Mild to moderate pulmonary impairment (lower DLCO) allowed but patients would not receive study carmustine

• Patients unable to complete pulmonary function test due to bone pain or fracture must have high-resolution CT scan of the chest and arterial partial pressure of oxygen greater than 70

Other

• No active infections requiring IV antibiotics

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Prior pulse dexamethasone (1-2 courses) allowed

• Concurrent pulse dexamethasone allowed during mobilization therapy

Radiotherapy

• Not specified

Surgery

• Not specified