Status:
ACTIVE_NOT_RECRUITING
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
Lead Sponsor:
Paul Richardson, MD
Collaborating Sponsors:
Celgene Corporation
Millennium Pharmaceuticals, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 eff...
Detailed Description
The drugs, lenalidomide, bortezomib, and dexamethasone, are approved by the FDA. They have not been approved in the combination for multiple myeloma or any other type of cancer. Bortezomib is currentl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Pregnant or lactating female
- Prior systemic therapy for MM (localized radiotherapy allowed if at least 7 days before study entry, corticosteroids allowed if dose \</= equivalent of 160 mg 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
729 Patients enrolled
Trial Details
Trial ID
NCT01208662
Start Date
October 1 2010
End Date
December 1 2026
Last Update
January 6 2025
Active Locations (46)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona Comprehensive Cancer Center
Tucson, Arizona, United States, 85724
3
City of Hope
Duarte, California, United States, 91010
4
University of California at San Diego
La Jolla, California, United States