Clinical Trial: Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

This study is no longer recruiting patients.

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

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase III trial to study the effectiveness of melphalan followed by peripheral stem cell transplantation in treating patients who have multiple myeloma.

Condition Treatment or Intervention Phase
refractory plasma cell neoplasm
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
primary systemic amyloidosis
 Drug: filgrastim
 Drug: melphalan
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: peripheral blood stem cell transplantation
Phase III

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

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Study of High Dose Melphalan Followed By Peripheral Blood Stem Cell Transplantation as Standard Therapy in Patients With Symptomatic Multiple Myeloma

Further Study Details: 

OBJECTIVES:

  • Administer standard, high dose melphalan safely in a closely monitored setting in patients with responsive multiple myeloma.
  • Determine the cost and time effectiveness in the collection of sufficient peripheral blood stem cells (PBSC) for two high dose melphalan therapies and PBSC transplantations in this patient population.

OUTLINE: Patients not in remission receive 3-6 courses of remission induction therapy consisting of either an anthracycline/glucocorticoid regimen or high dose glucocorticoids.

At 21-45 days following induction therapy, patients receive filgrastim (G-CSF) subcutaneously daily for 4 days followed by daily peripheral blood stem cell (PBSC) collection beginning on day 4 and continuing until the target number of cells is reached.

At 5 days to 6 weeks following PBSC collection, patients receive high dose melphalan IV over 2 hours for 2 consecutive days. At 36-48 hours following completion of melphalan, patients receive infusion of PBSC followed by G-CSF subcutaneously daily until blood counts recover.

At 3 months to 5 years following high dose therapy and PBSC infusion, patients with evidence of disease progression receive an additional treatment with high dose melphalan followed by PBSC infusion as in the first course.

Patients are followed at 30-45 days, 6 months, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60-120 patients will be accrued for this study over 5 years.

Eligibility

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed active multiple myeloma defined by:
  • Lytic disease
  • Anemia
  • Hypercalcemia
  • Secondary renal insufficiency
  • More than 400 mg/24 hours of urinary protein excretion
  • Symptomatic hyperviscosity
  • If previously treated, refractory to no more than 1 regimen
  • Primary amyloidosis without subsequent multiple myeloma allowed
  • Abnormal renal function allowed if due to primary disease

PATIENT CHARACTERISTICS: Age:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • See Disease Characteristics
  • Creatinine clearance greater than 50 mL/min if no renal impairment

Cardiovascular:

  • No cardiac function that would preclude study
  • LVEF greater than 45%

Pulmonary:

  • No pulmonary function that would preclude study
  • FVC greater than 60% predicted
  • DLCO greater than 50% predicted

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • No greater than 18 months of prior alkylator exposure

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • See Disease Characteristics
  • No more than 3 prior treatment regimens allowed

Location Information


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

Study chairs or principal investigators

Ann Traynor, MD,  Study Chair,  Robert H. Lurie Cancer Center   

More Information

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

Study ID Numbers:  CDR0000067409; NU-97H6T; NCI-G99-1632
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004165
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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