Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Stanford University |
---|---|
Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00349778 |
This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma. The study is being performed to evaluate the efficacy and side effects of treatment. Specifically, the study is designed to reduce the risk of interstitial pneumonitis.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: cyclophosphamide Drug: etoposide Drug: BCNU Melphalan |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | High -Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma |
Estimated Enrollment: | 49 |
Study Start Date: | August 2006 |
We have performed over 200 autologous HCT for myeloma at Stanford using high-dose sequential therapy with a BCNU dose of 550 mg/m2 plus melphalan 200 mg/m2. Analysis of 196 patients treated this way demonstrates a median event-free survival of 36 months with a median overall survival of more than six years. The main toxicity of this therapy is related to BCNU-pneumonitis or interstitial pneumonitis (IP). This complication is related to the dose of BCNU and is well described in the literature(18). In our myeloma patients treated with this dose of BCNU the incidence of IP is 34%.
There have been recent studies evaluating the role of tandem autologous transplants for patients with multiple myeloma. These trials were based upon the hypothesis that performing tandem high-dose therapy regimens would lead to increased tumor cell kill, decreased tumor burden and an improvement in overall survival(9, 19). There are trials comparing single to double transplants that suggest there may be a benefit for tandem autologous transplants for event-free survival and overall survival (20-22). However, our results with high-dose sequential therapy including the dose-intense BCNU/Melphalan transplant demonstrates similar median event-free survival and overall survival when compared with the results of tandem transplant approaches.
The proposed trial will continue to use a high-dose sequential transplant approach, however, we will use a reduced dose of BCNU which we expect to be associated with a lower incidence of IP.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:- Multiple myeloma. Eligible patients may have early or relapsed disease. Patients must have Stage II-III disease or have progression after initial treatment of Stage I disease.
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: BMT Referrals 650-723-0822 | |
Contact: Cancer Clinical Trials Office (650) 498-7061 cctoffice@stanford.edu | |
Sub-Investigator: Laura Johnston | |
Sub-Investigator: Ginna Laport | |
Sub-Investigator: Robert Lowsky | |
Sub-Investigator: David Miklos | |
Sub-Investigator: Robert S Negrin | |
Sub-Investigator: Judith Anne Shizuru | |
Principal Investigator: Sally Arai |
Principal Investigator: | Sally Arai | Stanford University |
Study ID Numbers: | BMT183, 97115, BMT183, NCT00349778 |
Study First Received: | July 5, 2006 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00349778 |
Health Authority: | United States: Institutional Review Board |
Melphalan Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Cyclophosphamide |
Hemostatic Disorders Etoposide phosphate Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Etoposide Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Therapeutic Uses Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |