Clinical Trial: Melphalan and Amifostine Followed By Stem Cell Transplantation in Treating Patients With Multiple Myeloma

This study is not yet open for patient recruitment.

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: This phase II trial is studying how well giving melphalan together with amifostine followed by stem cell transplantation works in treating patients with stage I, stage II, or stage III multiple myeloma.

Condition Treatment or Intervention Phase
Drug Toxicity
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
 Drug: amifostine
 Drug: melphalan
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemoprotection
 Procedure: chemotherapy
 Procedure: complications of therapy assessment/management
 Procedure: high-dose chemotherapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: supportive care/therapy
Phase II

MedlinePlus related topics:  Multiple Myeloma;   Poisoning

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of High-Dose Melphalan With Amifostine Followed By Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma

Further Study Details: 

OBJECTIVES: Primary

Secondary

  • Determine event-free survival, overall survival, and transplant-related mortality (defined as death within the first 30 days after transplantation) of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Correlate known prognostic factors (e.g., PCLI, β2-microglobulin, and fluorescence hybridization for chromosome 13 abnormalities and chromosome 14 translocations) with treatment response and outcomes in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo peripheral blood stem cell apheresis. Patients receive amifostine IV over 5 minutes on days -2 and -1 and high-dose melphalan IV over 5-10 minutes on day -1. Patients undergo autologous peripheral blood stem cell transplantation on day 0.

Patients are followed every 3 months for 3 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 10 months.

Eligibility

Ages Eligible for Study:  18 Years   -   64 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma
  • Symptomatic disease requiring treatment
  • Stage I, II, or III disease
  • Adequate number of CD34-positive cells for autologous hematopoietic stem cell transplantation
  • Must not have progressed after 1 prior chemotherapy regimen as determined within the past 28 days by the following:
  • Serum protein electrophoresis and immunofixation
  • Urine protein electrophoresis and immunofixation
  • Bone marrow biopsy and aspirate

PATIENT CHARACTERISTICS: Age

  • 18 to 64

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • AST and ALT ≤ 2 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN

Renal

  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No uncontrolled hypertension
  • No congestive heart failure
  • No angina pectoris
  • No major ventricular arrhythmia
  • No myocardial infarction within the past 6 months
  • LVEF ≥ 45% by MUGA

Pulmonary

  • DLCO ≥ 40%
  • FEV_1 ≥ 60% of predicted

Other

  • No active infection
  • No history of allergic reaction to amifostine
  • No diabetes mellitus
  • No other serious medical or psychiatric illness that would preclude study participation
  • No other malignancy within the past 2 years except basal cell or squamous cell skin cancer or carcinoma of the cervix
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

  • No prior stem cell transplantation
  • No concurrent biologic therapy

Chemotherapy

  • See Disease Characteristics
  • At least 28 days since prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

Radiotherapy

Surgery

  • Not specified

Other

  • Concurrent bisphosphonates allowed as supportive care

Location Information

Study chairs or principal investigators

David H. Vesole, MD, PhD,  Study Chair,  Medical College of Wisconsin   
Neal Flomenberg, MD,  Kimmel Cancer Center (KCC)   

More Information

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

Study ID Numbers:  CDR0000373893; ECOG-E2A03; NCT00087321
Record last reviewed:  September 2004
Last Updated:  March 21, 2005
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00087321
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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