Clinical Trial: Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Robert H. Lurie Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have multiple myeloma.

Condition Treatment or Intervention Phase
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory plasma cell neoplasm
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: etoposide
 Drug: interferon alfa
 Drug: melphalan
Phase II

MedlinePlus related topics:  Immune System and Disorders;   Lymphatic Diseases;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of High Dose Late Intensification Therapy in Patients With Chemotherapy Sensitive Multiple Myeloma

Further Study Details: 

Study start: October 1999

OBJECTIVES: I. Determine the feasibility and activity of intensive therapy with 3 noncross resistant chemotherapeutic regimens (cyclophosphamide, etoposide, cisplatin, cytarabine, and tandem courses of high dose melphalan with stem cell rescue) in patients with chemotherapy sensitive multiple myeloma. II. Determine the incidence of hematologic and nonhematologic toxicities of this regimen in this patient population. III. Determine the time to hematologic recovery after high dose melphalan in these patients. IV. Determine the response rate after each course of therapy in these patients. V. Determine the disease free, relapse free, and overall survival of these patients treated on this regimen. VI. Determine the incidence of toxicities attributable to interferon alfa and the ability to continue interferon alfa therapy as maintenance in these patients.

PROTOCOL OUTLINE: Patients are stratified according to the number of prior treatments (1 vs 2). Patients receive cyclophosphamide IV over 1 hour every 3 hours for 5 doses. Filgrastim (G-CSF) is administered subcutaneously daily beginning 3 days after cyclophosphamide and continuing through apheresis. Upon hematologic recovery, peripheral blood stem cells (PBSC) are collected over several days. After completion of the autologous stem cell harvest and hematologic recovery, patients receive etoposide IV and cisplatin IV continuously over 4 days, followed by cytarabine IV over 2 hours. Beginning 4-6 weeks later, patients receive melphalan IV over 15 minutes on 2 consecutive days. At least 48 hours after the second dose of melphalan, PBSC are reinfused. G-CSF is administered subcutaneously daily beginning 5 days after PBSC reinfusion until hematologic recovery. Patients remaining in remission after the first course of high dose melphalan receive a second course of melphalan 4 to 6 months after the first course. Melphalan IV is administered as above with reinfusion of the remainder of PBSC. After hematologic recovery from the second transplant, patients receive interferon alfa subcutaneously 3 days weekly until relapse. Patients are followed every 2 months.

PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:  up to  65 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: Not specified
  • Chemotherapy: See Disease Characteristics; No more than 2 prior chemotherapy regimens, including induction
  • Endocrine therapy: Not specified
  • Radiotherapy: Not specified
  • Surgery: Not specified

--Patient Characteristics--

  • Age: Physiologic 65 and under
  • Performance status: CALGB 0-1
  • Life expectancy: Not specified
  • Hematopoietic: Not specified
  • Hepatic: Bilirubin no greater than 2.0 mg/dL; No active hepatitis with hepatitis C
  • Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min
  • Cardiovascular: LVEF at least 45%; No history of symptomatic coronary artery disease unless cleared after cardiology evaluation
  • Pulmonary: FEV1 at least 60% predicted; FEV1/FVC at least 60%
  • Other: HIV negative; Hepatitis B surface antigen negative

Location Information


Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611,  United States

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States

Study chairs or principal investigators

Jane N. Winter,  Study Chair,  Robert H. Lurie Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067582; NU-C94H1; NCI-G00-1690; NU-94H1; UCCRC-7071
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004903
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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