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

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Overview

The purpose of this study is to test whether RO6870810 is safe at different dose levels, to find out what effects, good or bad, RO6870810 has on you and your disease as monotherapy or in combination with daratumumab in participants with relapsed/refractory multiple myeloma.

This drug has been tested in a limited number of humans (< 100), and this is the first time that RO6870810 will be given to patients with multiple myeloma.

SparkCures ID 875
Trial Phase Phase 1
Enrollment 86 Patients
Treatments
Trial Sponsors
  • Hoffmann-La Roche
NCT Identifier

NCT03068351

Am I Eligible?

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.

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

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
  • 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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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