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Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical research trials and Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma. Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma clinical trial. Test subjects typically receive the most effective healthcare possible for their Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma  Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
For Condition: refractory plasma cell neoplasm,primary systemic amyloidosis,stage 1 multiple myeloma,stage 2 multiple myeloma,stage 3 multiple myeloma
Status: No longer recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnnTraynor, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: CDR0000067409; NU-97H6T,NCI-G99-1632
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004165
Other Refractory Plasma Cell Neoplasm Studies:
1. Combination Chemotherapy With or Without Interferon alfa in Treating Patients With Previously Untreated Multiple Myeloma
2. Filgrastim Compared With Sargramostim Plus Chemotherapy, Peripheral Stem Cell Transplantation, and Interferon alfa in Treating Patients With Multiple Myeloma
3. Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
4. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
5. Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
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