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Bristol-Myers announces US FDA lifts partial clinical holds on two opdivo-based combo studies in multiple myeloma

Princeton, New Jersey
Thursday, December 7, 2017, 18:00 Hrs  [IST]

Bristol-Myers Squibb Company has announced the US Food and Drug Administration (FDA) has lifted partial clinical holds placed on CA209 -039 (CheckMate -039) and CA204142, the phase 1 and 2 clinical trials investigating Opdivo (nivolumab)-based combinations in patients with relapsed or refractory multiple myeloma, respectively. The decision follows consultation with the FDA and agreement on amendments to the study protocols. Patient enrollment for the following trials will resume in accordance with the amendments:

CheckMate -039: A phase 1 study to establish the tolerability of nivolumab and the combination of nivolumab and daratumumab, with or without IMiD (pomalidomide and dexamethasone), in subjects with relapsed or refractory MM

CA204142: A phase 2, multiple cohort study of elotuzumab in combination with pomalidomide and low-dose dexamethasone (EPd), and in combination with nivolumab (EN), in patients with multiple myeloma relapsed or refractory to prior treatment with lenalidomide

A third multiple myeloma trial, CA209 -602 (CheckMate -602), remains on partial clinical hold. Bristol-Myers Squibb is continuing to work with the FDA to determine next steps for this trial. The study is not enrolling new patients, however, patients who are experiencing clinical benefit are continuing to receive treatment.

Bristol-Myers Squibb continues to be committed to improving outcomes for patients with multiple myeloma.


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