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

Overview

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.

SparkCures ID 9
Trial Phase Phase 3
Enrollment 660 Patients
Treatments
Trial Sponsors
  • Dana-Farber Cancer Institute (Main)
Trial Collaborators
  • Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb
NCT Identifier

NCT01208662

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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
  • 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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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