Trial Search Results

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

The purpose of this study is to test whether RO6870810 is safe at different dose levels when given in combination with another drug, daratumumab, and to find out what effects, good or bad, RO6870810 has on you and your disease.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Stanford Investigator(s):

Intervention(s):

  • Drug: RO6870810
  • Biological: daratumumab

Phase:

Phase 1

Eligibility


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.

   - Prior treatment: 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 anti-CD38
   antibody (e.g., daratumumab, isatuximab) treatment is acceptable only for participants
   receiving monotherapy treatment.

   - Prior treatment: Treated with two or more lines of prior therapy, with disease
   refractory to both a proteasome inhibitor and an immunomodulatory agent, and disease
   progression (as defined by International Myeloma Working Group (IMWG) criteria)
   following treatment with an anti-CD38 monoclonal antibody given as monotherapy or in
   combination therapy. The most recent treatment regimen must have contained an
   anti-CD38 monoclonal antibody.

   - Treatment with prior autologous transplant is permitted

   - Documented diagnosis of symptomatic multiple myeloma, as defined by the 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 < 1% per year during the treatment period and for at least 2 months after the last
   dose of RO6870810 as monotherapy, or for at least 3 months after the last dose of
   daratumumab.

   - 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    cancer

   - 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.

   - Consumption of agents which strongly inhibit CYP3A4 enzyme, within 7 days prior to the
   first dose of study treatment and during the study.

   - Consumption of agents which strongly induce CYP3A4 enzyme, within 14 days prior to the
   first dose of study treatment and during the study.

   - Surgery within 21 days prior to study entry.

   - 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

   - Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, and
   immunotherapy) within 14 days except for alkylating agents (e.g., melphalan) within 28
   days.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jeffrey N. Sanders
6507244926
Recruiting