Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

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)

Key facts

Study ID

NCT01335399

Run by

Bristol-Myers Squibb

People needed

748

Starts

2011-08-04

Expected to finish

2021-09-03

Last updated by the study team

2022-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old

You may not qualify if…

• 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
• Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Where it is running

• Local Institution - 7619 — Mobile, Alabama, United States
• Local Institution - 7618 — Mobile, Alabama, United States
• Local Institution - 7617 — Chandler, Arizona, United States
• Local Institution - 1644 — Tucson, Arizona, United States
• Local Institution - 1618 — Bakersfield, California, United States
• Local Institution - 1602 — Berkeley, California, United States
• Local Institution - 1636 — Corona, California, United States
• Local Institution - 1668 — Corona, California, United States
• Local Institution - 1616 — Greenbrae, California, United States
• Local Institution - 7609 — Long Beach, California, United States
• Local Institution - 1660 — Los Angeles, California, United States
• Local Institution - 1673 — Orange, California, United States
• Local Institution - 1613 — San Diego, California, United States
• Local Institution - 1621 — New Haven, Connecticut, United States
• Local Institution - 1612 — Washington D.C., District of Columbia, United States
• Local Institution - 1682 — Boca Raton, Florida, United States
• Local Institution - 1617 — Brooksville, Florida, United States
• Local Institution - 1648 — Fort Myers, Florida, United States
• Local Institution - 7613 — Hollywood, Florida, United States
• Local Institution - 1623 — Jacksonville, Florida, United States
• Local Institution - 1625 — New Port Richey, Florida, United States
• Local Institution - 1649 — St. Petersburg, Florida, United States
• Local Institution - 1611 — West Palm Beach, Florida, United States
• Local Institution - 1630 — Atlanta, Georgia, United States
• Local Institution - 1628 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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