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Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation Clinical research trials and Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation. Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation clinical trial. Participants frequently get the best healthcare available for their Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation  Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation
Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation
For Condition: refractory plasma cell neoplasm
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with multiple myeloma that has recurred following bone marrow transplantation. PURPOSE: Phase II trial to study the effectiveness of white blood cells from a donor in treating patients with recurrent multiple myeloma following bone marrow transplantation.
Details: OBJECTIVES: - Assess the response rate of patients with recurrent multiple myeloma after an allogeneic marrow transplant from a genotypically HLA identical sibling donor treated with donor lymphocyte infusions as salvage therapy . - Evaluate the safety and toxicity of this treatment when used as salvage therapy in these patients. OUTLINE: Patients receive initial cell dose of donor lymphocytes (CD3+ cells) IV over 15-30 minutes. Patients with rapidly progressive disease may skip the initial cell dose and proceed directly to dose escalation to receive CD3+ cells at a higher cell dose. Patients who achieve complete response to the initial treatment may receive up to 2 additional courses of escalating doses of CD3+ cells 8-12 weeks apart in the absence of unacceptable toxicity. Patients are evaluated at 4 and 8 weeks after each infusion. Patients with disease progression at 8 weeks are retreated at that time. Patients who achieve partial response or stable disease at 8 weeks are re-evaluated at 12 weeks and may then be retreated. Patients are followed every 2 weeks for 3 months, once a month for 9 months, and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed recurrent or persistent multiple myeloma at least 6 months following allogeneic bone marrow transplantation (BMT) from an HLA identical sibling - Must meet one of following criteria to be considered persistent, recurrent, or progressive disease: - Residual detectable disease 6-12 months after BMT, as determined by the M protein level or bone marrow involvement, without further evidence of clinical or laboratory improvement on 2 consecutive measurements 4 weeks apart - Complete response not achieved 12 or more months after BMT and there is no evidence of progressive improvement - At least 25% increase of serum paraprotein (greater than 1.0 g/dL) as measured on two occasions or a 50% increase in urinary light chain excretion (greater than 150 mg/day) as measured on 2 occasions - A 10% increase in plasma cells in the bone marrow - Disease in complete response but with recurrence of M protein and 10% point increase in myeloma cells in the marrow allowed - No lytic lesions alone or new soft tissue plasmacytoma as sole evidence of progression PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - More than 4 weeks Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2.0 times upper limit of normal Renal: - Not specified Other: - No active infection - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Must have received prior allogeneic bone marrow transplantation from an HLA A;B;DR genotypically matched sibling donor - No concurrent interferon therapy for relapsed disease Chemotherapy: - At least 4 weeks since cyclosporine, methotrexate, azathioprine, or other graft versus host disease (GVHD) prophylaxis/treatment without evidence of flare of GVHD - At least 4 weeks since prior chemotherapy for relapsed disease Endocrine therapy: - Must be receiving a dose no greater than 0.25 mg/kg prednisone for at least 4 weeks prior to registration without flare of GVHD - No prior prednisone dose greater than 0.25 mg/kg in the past 4 weeks - Must receive concurrent prednisone of a dose no greater than 0.25 mg/kg - Concurrent corticosteroids allowed Radiotherapy: - Concurrent palliative radiotherapy allowed if evidence of other evaluable disease other than irradiated bony sites Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NealFlomenberg, Study Chair, Kimmel Cancer Center (KCC)
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226-3596
United States
Recruiting David Vesole 414-805-4646
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Michael Atkins 617-667-1930
Additional Information:
Study ID Numbers: CDR0000065938; ECOG-1A97
Study Start Date:
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003153
Other Refractory Plasma Cell Neoplasm Studies:
1. Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma
2. Antineoplaston Therapy in Treating Patients With Multiple Myeloma
3. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia
4. Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma
5. CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other Wisconsin Clinical Trials
Other Milwaukee Clinical Trials
Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation
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