To confirm the maximum tolerated dose (MTD) from the BI 836909 trial of 400 mcg/d, given as 28-day continuous intravenous infusion in patients with relapsed and/or refractory multiple myeloma, to test the 600 mcg/d dose, given as a 28-day continuous iV infusion, and to expand on the dose determined as the Recommended Phase 2 Dose (RP2D).
Cohort 1 will consist of 10 subjects dosed at 400 mcg/d. Cohort 2 will consist of 10 subjects dosed at 600 mcg/d. Cohort 3 (Phase 2) will consist of 100 subjects dosed at 400 mcg/d. If the 600 mcg/d dose is determined to be superior, Phase 2 subjects may potentially receive this dose. All doses will be given as a 28-day continuous IV infusion, followed by a 2 week treatment-free interval, until subject experiences disease progression as per International Myeloma Working Group (IMWG) criteria.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
The following is a listing of trial locations that are not currently open and accepting patients.
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