Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma

• Status: Completed
• Trial end date: 2018-01-09
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies, such as interferon alfa, use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma.

PURPOSE: This phase II trial is studying combination chemotherapy, peripheral stem cell transplantation, biological therapy, pamidronate, and thalidomide to see how well they work in treating patients with stage I, stage II, or stage III multiple myeloma.

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

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Cyclophosphamide; Interferon-alpha; Interferons; Lenograstim; Melphalan; Pamidronate; Sargramostim; Thalidomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage I-III multiple myeloma

• Less than 18 months since diagnosis

• Smoldering myeloma allowed if there is evidence of progressive disease requiring therapy

• At least 25% increase in M protein levels or Bence Jones excretion

• Hemoglobin no greater than 10.5 g/dL

• Hypercalcemia

• Frequent infections

• Rise in serum creatinine above normal on 2 separate occasions

• Nonquantifiable monoclonal proteins allowed if other criteria for multiple myeloma or smoldering myeloma are met

• Response/status after induction therapy:

• Responding or stable disease AND no greater than 40% myelomatous involvement of bone marrow

• No Waldenstrom's macroglobulinemia

PATIENT CHARACTERISTICS:

Age:

• 65 and under

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• Serum glutamic axaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 2.5 times upper limit of normal

• Hepatitis B antigen or hepatitis C ribonucleaic acid (RNA) negative

Renal:

• See Disease Characteristics

• Creatinine no greater than 1.4 mg/dL

• Creatinine clearance greater than 65 mL/min

Cardiovascular:

• Cardiac ejection fraction at least 50% by multigated acquisition scan (MUGA) or echocardiogram

Pulmonary:

• Forced-expiratory volume in one second (FEV_1) greater than 60% of normal

• Diffusing capacity for carbon monoxide (DLCO) greater than 50% of predicted lower limit

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• Human immunodeficiency virus (HIV) negative

• No other medical or psychosocial problems that would increase patient risk

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

• No known hypersensitivity to filgrastim (G-CSF) or Escherechi coli-derived proteins

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No more than 3 prior chemotherapy regimens

• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• Not specified