Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Intervention: filgrastim; recombinant interferon alfa; busulfan; cyclophosphamide; melphalan; pamidronate disodium; thalidomide; peripheral blood stem cell transplantation
Intervention MeSH terms: Pamidronate; Interferons; Interferon-alpha; Thalidomide; Cyclophosphamide; Melphalan; Busulfan; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Maximum age: 65 Years
Healthy volunteers: No
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

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.
    

Eligibility 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