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Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma conditions. Clinical Trials Search.org is a site dedicated 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 health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like 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 volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma clinical trial. Human subjects often get the best healthcare available for their Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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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 Stage 2 Multiple Myeloma Studies:
1. CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma
2. Interleukin-12 in Treating Patients With Multiple Myeloma
3. O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
4. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
5. Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Related Studies:
Other stage 2 multiple myeloma 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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