Multiple Myeloma
Lenalidomide/Dexamethasone for Newly Diagnosed Myeloma (2521)
A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone with or without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma
| Status | Conditions | Phase | Study ID |
| Recruiting | Multiple Myeloma | Phase III |
2521 NCT01335399 |
Summary
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).
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Eligibility Criteria (must meet the following to participate in this study)
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Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
- have not received any prior systemic anti-myeloma therapy AND
- have measurable disease AND
- are not candidates for high-dose therapy plus stem-cell transplantation because of age (≥ 65 years) or coexisting conditions
Exclusions (conditions that would prevent participation in this study)
- Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
- Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Active plasma cell leukemia
- Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)
Last Updated
March 20, 2012See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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