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Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced 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, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma Clinical research trials and Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced 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, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma. Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced 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, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma clinical trial. Human subjects often get the best healthcare available for their Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced 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, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma  Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma
Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma
For Condition: stage 3 multiple myeloma,stage 2 multiple myeloma,stage 1 multiple myeloma,refractory plasma cell neoplasm
Status: Suspended
Sponsor(s): Fred Hutchinson Cancer Research 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. Interleukin-2 may stimulate a person's white blood cells to kill multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells. PURPOSE: Phase II trial to study the effectiveness of melphalan, peripheral stem cell transplantation, and interleukin-2 followed by interferon alfa in treating patients who have advanced multiple myeloma.
Details: OBJECTIVES: - Determine initial response to therapy, time to disease progression, and overall survival of patients with advanced multiple myeloma treated with autologous or syngeneic peripheral blood stem cell transplantation, melphalan, and interleukin-2 followed by interferon alfa. - Compare the toxic effects encountered by patients under age 56 (closed to accrual as of 9/1/03) vs patients age 56 and over treated with this regimen. OUTLINE: Patients are stratified according to age (18 to 55 [closed to accrual as of 9/1/03] vs 56 and over). Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of interleukin-2 (IL-2)-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days. Treatment with IL-2 repeats weekly for 4 weeks. Maintenance therapy begins 1 month after IL-2 treatment. Patients receive interferon alfa subcutaneously 3 times a week in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 3 years and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) (age 18 to 55 stratum closed to accrual as of 9/1/03) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/69 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of advanced multiple myeloma meeting 1 of the following staging criteria: - Diagnosis of stage II or III disease initially - Stage I disease refractory to or progressed after initial therapy - Meets 1 of the following criteria: - Has an identical syngeneic twin - Meets eligibility requirements for mobilization/debulking with cyclophosphamide/etoposide/filgrastim (G-CSF), cyclophosphamide/G-CSF, or cyclophosphamide/paclitaxel/G-CSF (protocol FHCRC-506STP) - No pleural or pericardial effusion or ascites PATIENT CHARACTERISTICS: Age: - 18 to 69 (age 18 to 55 stratum closed to accrual as of 9/1/03) Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 1.5 mg/dL (unless there is a history of Gilbert's disease) - SGOT or SGPT no greater than 2 times upper limit of normal - Hepatitis C or B negative Renal: - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - LVEF at least 50% - No congestive heart disease - No prior myocardial infarction - No coronary artery disease - No prior arrhythmia Pulmonary: - DLCO at least 60% - FEV1 at least 65% of predicted Other: - No other malignancies within the past 5 years except basal cell skin cancer or carcinoma in situ - No history of seizures - No active connective tissue disease - No allergy to gentamicin - No hypersensitivity to E. coli-derived preparations - No systemic infection - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent growth factors Chemotherapy: - See Disease Characteristics - At least 30 days since prior chemotherapy Endocrine therapy: - No concurrent corticosteroids Radiotherapy: - Not specified Surgery: - Not specified Other: - No concurrent medications (e.g., haloperidol) for controlling mental disorders - No contrast dyes during and for 3 weeks after study participation
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeonaHolmberg, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Additional Information:
Study ID Numbers: CDR0000068172; FHCRC-1461.00,NCI-G00-1845
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006244
Other Refractory Plasma Cell Neoplasm Studies:
1. CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma
2. Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma
3. Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma
4. Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
5. Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma
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