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A Randomized, Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib, and Dexamethasone (RVD) to High-Dose Treatment With Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients Up to 65 Years of Age

In this research study, we are looking to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients.

Stanford is now accepting new patients for this trial.

Investigator(s):

Intervention(s):

  • drug : Lenalidomide
  • drug : Bortezomib
  • drug : Dexamethasone
  • procedure : Autologous Stem Cell Transplant

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - 65 Years

Inclusion Criteria

- Diagnosis of Multiple Myeloma, according to the International Myeloma Foundation 2003 Diagnostic Criteria - Documented symptomatic myeloma, with organ damage related to myeloma with laboratory assessments performed within 21 days of registration - Myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains. - ECOG performance status </= 2 - Negative HIV blood test - Voluntary written informed consent

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Uzma Ahmed
650-723-0670
Recruiting

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