Trial ID or NCT#

NCT03068351,

Status

RECRUITING

Purpose

This is a Phase Ib, open-label, multicenter, global study designed to assess the safety and tolerability of RO6870810 as monotherapy and in combination with daratumumab in participants with relapsed/refractory multiple myeloma. Each treatment cycle will be 21 days in length. There are two parts to this study. A dose-escalation phase (Part I) will be used to evaluate the safety and tolerability and dose limiting toxicities, and to establish the maximum tolerated dose (MTR)/optimum biological dose (OBD) of RO6870810 when given as monotherapy or in combination with daratumumab. A dose-expansion phase (Part II) will further characterize the safety, tolerability and activity of RO6870810 as monotherapy or in combination with daratumumab at the defined expansion dose-levels.

Official Title

Open-label, Multicenter, Dose-escalation/Expansion Phase Ib Study to Evaluate Safety, Pharmacokinetics, and Activity of BET Inhibitor RO6870810, Given as Mono- and Combination Therapy to Patients With Advanced Multiple Myeloma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Michaela Liedtke
Hematologist, Medical oncologist, Multiple myeloma specialist, Leukemia specialist
Associate Professor of Medicine (Hematology) at the Stanford University Medical Center
Rondeep Brar
Hematologist, Leukemia specialist, Medical oncologist
Clinical Associate Professor, Medicine - Hematology

Contact us to find out if this trial is right for you.

CONTACT

Jeffrey N. Sanders
(650) 724-4926