Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00040937

S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

Official Title:

A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)

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

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

Disease(s) and\or Condition(s)

Multiple Myeloma

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: filgrastim
    • Description: PBSC collection: 10 mcg/kg SQ days 1-10
    • Arm Group Labels: treatment arm
    • Type: BIOLOGICAL
    • Name: sargramostim
    • Description: PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis 1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery
    • Arm Group Labels: treatment arm
    • Type: DRUG
    • Name: cyclophosphamide
    • Description: PBSC collection: 1 mg/m2 IV over 45-60 mins day 0
    • Arm Group Labels: treatment arm
    • Type: DRUG
    • Name: dexamethasone
    • Description: 40 mg/d PO days 1-4, 9-12, 17-20
    • Arm Group Labels: treatment arm
    • Type: DRUG
    • Name: melphalan
    • Description: 1. st trans: 140 mg/m2 IV over 20 mins day -1 2. nd trans: 200mg/m2 IV over 20 mins day -1
    • Arm Group Labels: treatment arm
    • Type: DRUG
    • Name: prednisone
    • Description: maint: 50 mg/d PO every other day until progression
    • Arm Group Labels: treatment arm
    • Type: DRUG
    • Name: thalidomide
    • Description: 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
    • Arm Group Labels: treatment arm
    • Type: PROCEDURE
    • Name: peripheral blood stem cell transplantation
    • Description: 2-4 x 10\^6/kg IV day 0
    • Arm Group Labels: treatment arm
Sponsor
  • SWOG Cancer Research Network