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

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Multiple Myeloma

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the risk of interstitial pneumonitis with the current dosing of BCNU and melphalan

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Sally Arai

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

August 2006

Completion Date:

April 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Stanford University School of Medicine Stanford, California  94305-5317