Phase I Dose Escalation of i.v. BI 836909 Monotherapy in Last Line Multiple Myeloma Patients
Status:
Completed
Trial end date:
2020-07-02
Target enrollment:
Participant gender:
Summary
The primary objective of this trial is to determine the maximum tolerated dose (MTD) of BI
836909 administered by continuous i.v. infusion in patients with relapsed and/or refractory
multiple myeloma. If the MTD is not reached based on safety findings, a recommended dose for
further development will be determined. This will depend on the safety data,
pharmacokinetic/pharmacodynamics data and potentially preliminary efficacy data. Secondary
objectives are to document the safety and tolerability of BI 836909, to perform
pharmacokinetic and pharmacodynamic analyses and to evaluate relevant biological effects in
terms of parameters of efficacy.