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RVD Alone or Combined With Autologous Stem Cell Transplant in Myeloma

Clinical Trial Title: 
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.
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
John J. Maciejewski, MD, PhD
Clinical Trial Protocol Description: 

The purpose of the trial is to assess a value of early versus delayed autologous bone marrow transplant in the era of novel agents.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria: 

  • Have symptomatic multiple myeloma by IMF 2003 diagnostic criteria, with myeloma-related organ damage (CRAB criteria).
  • Have measurable disease in serum, urine, and/or serum.
  • Have a FLC assay. (FLC patients not measurable by urine or serum evaluation may be considered.)
  • Be age 18-65 at time of consent with adequate performance status, able to care for self and perform activities of daily living.
  • Have HIV negative status.

You will be excluded from the study if any of the following criteria apply to you:

  • Have no prior systemic therapy for myeloma or are receiving other investigational agents.
  • Have primary amyloidosis or myeloma complicated by amylosis, known brain metastases, moderate-severe peripheral neuropathy at baseline, hepatic impairment, renal insufficiency, respiratory compromise, clinical signs of heart or coronary failure (LVEF must be >40%), other concurrent illness and/or situation that may limit study compliance or inability to comply with required anti-thrombotic treatment.
  • Have hemoglobin < 8.0g/dL (transfusion is allowed to support eligibility), absolute neutrophil count < 1,000 cells/mm3 and/or platelets < 50,000/mm3 within 21d of initiation of protocol therapy. (Platelet transfusion and growth factor NOT allowed within 7d from screening.)
  • Have previous history of another malignant condition except for complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, good risk prostate CA after curative therapy, or stage 1 cervical CA. If invasive malignancy was experienced 2 or more years ago and confirmed as cured, these participants may be considered for the study with PI discussion and approval.
  • Are pregnant or breast-feeding female.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Blood Disorders and Hematologic Cancers
Contact Phone: 
(312) 942-5157
Contact Name: 
Agne Paner, MD