High -Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
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Purpose
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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | High -Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma |
- Evaluate the risk of interstitial pneumonitis with the current dosing of BCNU and melphalan [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Remission rate, event-free survival, overall survival and relapse [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 49 |
| Study Start Date: | August 2006 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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.
- Age 18-75 years.
- Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. Patients with smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or primary amyloidosis will be excluded from this study. Patients with multiple myeloma and amyloidosis may be eligible for this trial, with approval by the Principle Investigator.
- Patients must have a Karnofsky performance status > 70%.
- DLCO >=60% predicted.
- ALT and AST must be < 2X normal. Total bilirubin less than 2 mg/dl.
- Serum creatinine < 2.0 or 24-hour creatinine clearance e 60 ml/min.
- Patients must be HIV negative.
- Pregnant or lactating women will not be eligible to participate.
- Patients must provide signed, informed consent.
Exclusion Criteria:- Severe psychological or medical illness
- Patients who have undergone prior autologous hematopoietic cell transplantation will not be eligible for this study.
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Sally Arai | Stanford University |
More Information
No publications provided
| Responsible Party: | Sally Arai, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00349778 History of Changes |
| Other Study ID Numbers: | BMT183, 97115, BMT183 |
| Study First Received: | July 5, 2006 |
| Last Updated: | October 7, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Cyclophosphamide |
Melphalan Etoposide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 21, 2013