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Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis Clinical research trials and Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis clinical trial. Human subjects often get the best healthcare possible for their Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis  Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis
For Condition: refractory plasma cell neoplasm,primary systemic amyloidosis,stage 2 multiple myeloma,stage 1 multiple myeloma,stage 3 multiple myeloma
Status: Recruiting
Sponsor(s): Herbert Irving Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have multiple myeloma or primary systemic amyloidosis.
Details: OBJECTIVES: - Determine the response rate in patients with multiple myeloma or primary systemic amyloidosis treated with high-dose chemotherapy with autologous hematopoietic stem cell support. - Determine the toxicity of this regimen in these patients. - Determine the disease-free survival and overall survival of patients with multiple myeloma treated with this regimen. OUTLINE: Patients are stratified according to disease response to prior treatment (responsive vs refractory or relapsed) and diagnosis (multiple myeloma vs primary systemic amyloidosis). Following a course of induction chemotherapy, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until the completion of peripheral blood stem cell (PBSC) harvesting. Patient who do not mobilize sufficient cells undergo bone marrow harvest. Patients receive melphalan IV over 30 minutes on days -2 and -1. Half of the stored PBSCs and/or bone marrow is reinfused on day 0. Patients receive sargramostim (GM-CSF) daily beginning on day 0 and continuing until blood counts recover. Patients with primary systemic amyloidosis who are not responding to or are unable to tolerate treatment do not proceed to the second course of therapy. Within 4-6 weeks after receiving melphalan, patients receive oral busulfan on days -8 to -5 followed by cyclophosphamide IV continuously on days -4 and -3. The remaining half of PBSCs and/or bone marrow is reinfused on day 0. Patients receive GM-CSF daily beginning on day 0 and continuing until blood counts recover. Within 4-12 weeks after receiving the second course of high-dose chemotherapy, multiple myeloma patients receive maintenance therapy consisting of interferon alfa SC 3 days a week, after blood counts recover. Patients are followed every 3 months for 1 year and then annually for 5 years. PROJECTED ACCRUAL: Approximately 60-75 patients (25 for responsive disease stratum, 25 for refractory or relapsed disease stratum, and 10-25 for primary systemic amyloidosis stratum) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed multiple myeloma OR - Primary systemic amyloidosis resulting in significant organ dysfunction and decreased quality of life - Complete or partial response after standard chemotherapy - Primary refractory or relapsed multiple myeloma after first-line treatment with standard chemotherapy - Ineligible for higher priority national or institutional clinical studies PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin less than 2 times normal Renal: - Creatinine less than 2.5 mg/dL or on stable hemodialysis Cardiovascular: - LVEF at least 45% Pulmonary: - DLCO at least 60% of predicted OR - Approval by pulmonologist Other: - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - Concurrent participation in gene therapy trials allowed Chemotherapy: - See Disease Characteristics - No other concurrent chemotherapy Endocrine therapy: - No concurrent steroids as antiemetics during chemotherapy - No concurrent anticancer hormonal therapy Radiotherapy: - Not specified Surgery: - Not specified Other: - No concurrent barbiturates or acetaminophen during chemotherapy - Concurrent participation in supportive care trials allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesHesdorffer, Study Chair, Columbia University
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Charles Hesdorffer 212-305-4907
Additional Information:
Study ID Numbers: CDR0000068361; CPMC-CAMP-009,NCI-G00-1882,CPMC-IRB-7328
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007995
Other Stage 1 Multiple Myeloma Studies:
1. Chemotherapy, Holmium Ho 166 DOTMP, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
2. Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
3. Melphalan, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Multiple Myeloma
4. Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
5. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Related Studies:
Other stage 1 multiple myeloma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis
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