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

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ClinicalTrials.gov Identifier: NCT00004165
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 6, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

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 or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Biological: filgrastim Drug: melphalan Procedure: peripheral blood stem cell transplantation Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Stem Cell Transplant as Standard Therapy for Symptomatic Multiple Myeloma
Study Start Date : October 1999
Primary Completion Date : August 2003
Study Completion Date : August 2003






Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004165


Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
Study Chair: Ann Traynor, MD Robert H. Lurie Cancer Center

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00004165     History of Changes
Other Study ID Numbers: NU 97H6T
NU-97H6T
NCI-G99-1632
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: May 2012

Keywords provided by Northwestern University:
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
primary systemic amyloidosis

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs