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

Description

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/optimum biological dose 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.

Study Start Date

June, 26 2017

Estimated Completion Date

January 2020

Interventions

  • Drug: RO6870810
  • Biological: daratumumab

Study ID

Hoffmann-La Roche -- NP39403

Status

Recruiting

Trial ID

NCT03068351

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

86

Sponsor

Hoffmann-La Roche

Inclusion Criteria

  • Performance status Life expectancy > 3 months
  • Relapsed or refractory multiple myeloma. Participants with primary refractory myeloma only allowed in dose-escalation phase of the study.
  • Treated with at least three prior lines of multiple myeloma therapy including a proteasome inhibitor and an immuno modulatory agent or who are double refractory to a proteasome inhibitor and an immuno modulatory agent. Prior daratumumab treatment is acceptable only for participants receiving monotherapy treatment.
  • Treatment with prior autologous transplant is permitted
  • Documented diagnosis of symptomatic multiple myeloma, as defined by the International Myeloma Working Group (IMWG)
  • Measurable disease defined as at least one of the following: serum M-protein >/=1 grams/deciliter (g/dL), urine M-protein >/= 200 milligrams/24 hours (mg/24h), serum free light chain (SFLC) assay: involved SFLCs >/= 10 mg/dL (>/= 100 mg/L) and an abnormal SFLC ratio (<0.26 or >1.65).
  • Female participants of childbearing potential must have a negative serum pregnancy test within the 7 days prior to the first study drug administration.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 4 months after the last dose of RO6870810 as monotherapy, or for at least 3 months after the last dose of daratumumab.

Exclusion Criteria

  • Plasma cell leukemia defined as peripheral plasma cell count > 2000/cubic millimeter (mm^3)
  • For expansion cohorts only: Primary refractory multiple myeloma defined as disease that is non-responsive in participants who have never achieved a minimal response or better with any therapy
  • History of other malignancy within 2 years prior to screening, except for ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer (Gleason score POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
  • Current or prior disease or treatment that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor
  • Pregnant or breastfeeding female.
  • Prior treatment with any anti-CD38 therapy, including daratumumab (for participants receiving RO6870810 and daratumumab combination treatment)
  • Prior treatment with small molecule BET family inhibitor or receiving steroids >the equivalent of 10mg prednisone daily
  • participants who are currently receiving any other investigational agent or have received an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to study entry
  • Uncontrolled cancer pain

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (18)

Study Location Distance Name Phone Email
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Mount Sinai PRIME Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles None None None
Mount Sinai PRIME Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles None None None
Mount Sinai PRIME Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles None None None
Mount Sinai PRIME Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles None None None
Duke Clin Rsch Institute - Durham, North Carolina 609.0 miles None None None
Duke Clin Rsch Institute - Durham, North Carolina 609.0 miles None None None
University of North Carolina at Chapel Hill - Chapel Hill, North Carolina 615.9 miles None None None
Emory Uni Winship Cancer Center HematologyOncology - Atlanta, Georgia 932.0 miles None None None
Emory Uni Winship Cancer Center HematologyOncology - Atlanta, Georgia 932.0 miles None None None
Emory Uni Winship Cancer Center HematologyOncology - Atlanta, Georgia 932.0 miles None None None
Emory Uni Winship Cancer Center HematologyOncology - Atlanta, Georgia 932.0 miles None None None
Mayo Clinic - Jacksonville, Florida 1,015.8 miles None None None
University of Oklahoma Health Sciences Center Stephenson Cancer Center - Oklahoma City, Oklahoma 1,493.6 miles None None None
University of Oklahoma Health Sciences Center Stephenson Cancer Center - Oklahoma City, Oklahoma 1,493.6 miles None None None
University of Oklahoma Health Sciences Center Stephenson Cancer Center - Oklahoma City, Oklahoma 1,493.6 miles None None None
University of Oklahoma Health Sciences Center Stephenson Cancer Center - Oklahoma City, Oklahoma 1,493.6 miles None None None
City of Hope - Duarte, California 2,578.2 miles None None None

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