Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65

Not Recruiting

Trial ID: NCT01208662

Purpose

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. In this study, HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs progression-free survival by at least 9 months or more, recognizing that particular subgroups may benefit more compared to others.

Official 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

Stanford Investigator(s)

Michaela Liedtke
Michaela Liedtke

Associate Professor of Medicine (Hematology)

Eligibility


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
   - Negative HIV blood test

   - Voluntary written informed consent

Exclusion Criteria:

   - Pregnant or lactating female

   - Prior systemic therapy for MM (localized radiotherapy allowed if at least 7 days
   before study entry, corticosteroids allowed if dose    dexamethasone over 2 weeks)

   - 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 <50,000/mm3, within 21 days of registration

   - ANC <1,000 cells/mm3, within 21 days of registration

   - Hemoglobin <8 g/dL, within 21 days of registration

   - Hepatic impairment (>/= 1.5 x institutional ULN or AST (SGOT), ALT (SGPT), or alkaline
   phosphatase >2 x ULN). Patients with benign hyperbilirubinemia are eligible.

   - Renal insufficiency (serum creatinine >2.0 mg/dl or creatinine clearance <50 ml/min,
   within 21 days of registration)

   - Respiratory compromise (DLCO < 50%)

   - Clinical signs of heart or coronary failure or LVEF < 40%. Myocardial infarction
   within 6 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled
   angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
   of acute ischemia or active conductive system abnormalities

   - 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 basal cell carcinoma and
   stage I cervical cancer. If malignancy was experienced more than 2 years ago and
   confirmed as cured, these participants may be considered for the study on case by case
   basis with PI discussion.

   - Inability to comply with an anti-thrombotic treatment regimen

   - Peripheral neuropathy >/= Grade 2

Intervention(s):

drug: Lenalidomide

drug: Bortezomib

drug: Dexamethasone

procedure: Autologous Stem Cell Transplant

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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