S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: filgrastim; sargramostim; cyclophosphamide; dexamethasone; melphalan; prednisone; thalidomide; peripheral blood stem cell transplantation
Intervention description: PBSC collection: 10 mcg/kg SQ days 1-10; PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis
1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery; PBSC collection: 1 mg/m2 IV over 45-60 mins day 0; 40 mg/d PO days 1-4, 9-12, 17-20; st trans: 140 mg/m2 IV over 20 mins day -1
nd trans: 200mg/m2 IV over 20 mins day -1; maint: 50 mg/d PO every other day until progression; ind: 50 mg increased by 50 mg every week to max 400 mg PO qhs for 35 days maint: 50 mg/d increased by 50 mg every week to 200 mg PO daily until progression; 2-4 x 10^6/kg IV day 0
Intervention MeSH terms: Thalidomide; Dexamethasone; Prednisone; Cyclophosphamide; Melphalan; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Summary:

      RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the
      cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing
      so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may
      allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
      Giving thalidomide before and after peripheral stem cell transplant may be effective in
      treating newly diagnosed multiple myeloma.

      PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and
      peripheral stem cell transplant work in treating patients with newly diagnosed multiple
      myeloma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Newly diagnosed multiple myeloma requiring treatment

               -  Smoldering myeloma with evidence of progressive disease requiring chemotherapy

                    -  More than 25% increase in M component levels and/or Bence-Jones excretion or
                       symptom development

               -  Non-secretory patients with at least 30% bone marrow plasmacytosis

          -  No IgM peaks unless there is evidence of more than 30% bone marrow plasmacytosis or
             more than 3 lytic lesions

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 65

        Performance status

          -  Zubrod 0-2 OR

          -  Zubrod 3-4 based solely on bone pain

        Life expectancy

          -  Not specified

        Hematopoietic

          -  No untreated, unresolved symptomatic hyperviscosity

        Hepatic

          -  Hepatitis B negative

        Renal

          -  Creatinine no greater than 3 mg/dL if in renal failure and on dialysis (after
             hydration and/or correction of hypercalcemia)

        Cardiovascular

          -  No history of chronic cerebrovascular accident

          -  No myocardial infarction within the past 6 months

          -  No unstable angina

          -  No congestive heart failure that is difficult to control

          -  No uncontrollable hypertension

          -  No cardiac arrhythmia that is difficult to control

        Pulmonary

          -  No history of chronic obstructive or chronic restrictive pulmonary disease

          -  No untreated, unresolved pneumonia

          -  Pulmonary function tests (PFTs) at least 50% of predicted

          -  DLCO at least 50% of predicted

          -  Arterial partial pressure of oxygen greater than 70 if unable to complete PFTs due to
             bone pain or fracture

        Other

          -  HIV negative

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

          -  No untreated, unresolved pathologic fractures

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use at least 2 highly effective methods of contraception for 4
             weeks before, during, and for at least 4 weeks after study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No more than 8 weeks of prior thalidomide therapy

        Chemotherapy

          -  No prior chemotherapy for this disease

        Endocrine therapy

          -  Prior steroid therapy allowed provided treatment duration was no more than 2 weeks

        Radiotherapy

          -  No prior radiotherapy to more than 50% of the pelvis

        Surgery

          -  Not specified