Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Study Details
Study Description
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 |
|---|---|---|
|
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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosed active multiple myeloma defined by:
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Lytic disease
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Anemia
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Hypercalcemia
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Secondary renal insufficiency
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More than 400 mg/24 hours of urinary protein excretion
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Symptomatic hyperviscosity
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If previously treated, refractory to no more than 1 regimen
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Primary amyloidosis without subsequent multiple myeloma allowed
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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:
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No pulmonary function that would preclude study
-
FVC greater than 60% predicted
-
DLCO greater than 50% predicted
Other:
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Not pregnant or nursing
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NU 97H6T
- NU-97H6T
- NCI-G99-1632