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Clinical Trial 17747

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT01208662

Phase: Phase III
Principal Investigator: Alsina, Melissa

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Overview

Study 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 in Patients up to 65 Years of Age

Summary

The purpose of this study is 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.

Objective

To compare progression-free survival (PFS) between Arm A (RVD)and Arm B (RVD Auto PSCT)

Treatments

Therapies

Bone Marrow Transplant; Chemotherapy (NOS); Therapy (NOS)

Medications

Alkeran (Melphalan); Bortezomib (); CC-5013 (Lenalidomide); Dexamethasone (); Lenalidomide (Revlimid); Melphalan (); PS-341 (Bortezomib); Velcade (Bortezomib)

Inclusion Criteria

  • Age 18 years to 65 years
  • 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
  • Myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains
  • Eastern Cooperative Oncology Group (ECOG) performance status > Negative HIV blood test
  • Voluntary written informed consent

  • Exclusion Criteria

  • Females who are pregnant or lactating
  • Prior systemic therapy for MM (localized radiotherapy allowed if at least 7 days before study entry, corticosteroids for the treatment of their myeloma allowed if dose > Primary amyloidosis (AL) or myeloma complicated by amylosis
  • Receiving any other investigational agents
  • Known brain metastases
  • Poor tolerability or allergy to any of the study drugs or compounds of similar composition
  • Platelet count > ANC > Hemoglobin > Hepatic impairment (>/= 1.5 x institutional upper limit of normal (ULN) or AST (SGOT), ALT (SGPT), or alkaline phosphatase >2 x ULN). Potential participants with benign hyperbilirubinemia are eligible.
  • Renal insufficiency (serum creatinine >2.0 mg/dl or creatinine clearance > Respiratory compromise (carbon monoxide diffusing capacity (DLCO) > Clinical signs of heart or coronary failure or left ventricular ejection fraction (LVEF) > Intercurrent illness including, but not limited to ongoing or active severe infection, known infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements
  • Previous history of another malignant condition, except for localized cancers that have been adequately treated. This includes completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy, good risk prostate cancer after curative therapy and/or considered appropriate for watchful waiting, and stage I cervical cancer. If invasive malignancy was experienced 2 or more years ago and confirmed as cured, these participants may be considered for the study on case by case basis with principal investigator (PI) discussion.
  • Inability to comply with an anti-thrombotic treatment regimen
  • Peripheral neuropathy >/= Grade 2

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.