High -Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00349778
First received: July 5, 2006
Last updated: October 7, 2010
Last verified: October 2010
  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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Evaluate the risk of interstitial pneumonitis with the current dosing of BCNU and melphalan [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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)
Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349778

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Cyclophosphamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014