Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced Multiple Myeloma

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 26, 2017

Primary Completion Date

August 1, 2019

Study Completion Date

August 1, 2019

Conditions
Multiple Myeloma
Interventions
DRUG

RO6870810

RO6870810 will be administered subcutaneously (SC) at ascending-dose levels (from 0.30 milligrams/kilogram \[mg/kg\] to 0.65 mg/kg). In Cycle 1, RO6870810 will be given on Day 1 (omitted on Day 2) and then every day from Day 3 through to Day 15. Starting at Cycle 2, it will be given every day from Day 1 to Day 14 of each 21-day cycle. In the first combination therapy cohort RO6870810 will be administered at one dose-level below the maximum tolerated dose (MTD).

BIOLOGICAL

daratumumab

Daratumumab will be administered intravenously (IV) at a dose of 16 milligrams/kilogram (mg/kg) of body weight weekly for the first 8 weeks, every two weeks for the following 16 weeks, and every four weeks thereafter, until disease progression.

Trial Locations (12)

2031

Scientia Clinical Research Limited, Randwick

3065

St Vincent's Hospital Melbourne, Fitzroy

10029

Mount Sinai - PRIME; Icahn School of Medicine at Mount Sinai, New York

27514

University of North Carolina at Chapel Hill, Chapel Hill

27710

Duke Clin Rsch Institute, Durham

30322

Emory Uni - Winship Cancer Center; Hematology/Oncology, Atlanta

32224

Mayo Clinic, Jacksonville

91010

City of Hope, Duarte

94305-5820

Stanford Cancer Center, Stanford

02215

Dana Farber Cancer Institute, Boston

W1T 7HA

University College London Hospitals; Clinical Research Facility, London

Unknown

Oxford University Hospitals NHS Trust; Churchill Hospital, Oxford

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03068351 - Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced Multiple Myeloma | Biotech Hunter | Biotech Hunter