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.

How many people will take part in the study?

Approximately 86 patients will take part in this study. Approximately 28 patients will receive monotherapy and 58 patients will receive combination therapy of RO6870810 and daratumumab.

How will the study treatment be administered?

RO6870810 Injection

RO6870810 will be given at a dose based on your weight. It will be injected into the fatty layer of tissue between the skin and the muscle (subcutaneous injection). This is similar to how some vaccines are given.

During scheduled clinic visits, RO6870810 will be administered by a qualified health care professional or you (while being observed by the health care professional).

At home, all other doses in each cycle will be administered by yourself or a caregiver once a day at the same time each day. If you will be self-administering, you will be taught how and where to inject RO6870810 on your body. You (or a caregiver), or an optional mobile nursing service will give you the injections at home.

RO6870810 will need to be taken for 14 consecutive days, followed by a 7 day rest period in a 21 day cycle. Missed doses will not be made up. If you miss more than 4 doses during Cycle 1, you will be withdrawn from the study.

Daratumumab Infusion (for patients in the combination arm)

You will also receive daratumumab at a dose based on your weight. Daratumumab is given as an IV infusion in the clinic. The first infusion may last about 15 hours. All other infusions may be done in about 3 hours, but may be longer (up to 15 hours), depending on how you reacted to the first infusion. You will receive daratumumab weekly for the first 8 weeks, every two weeks for the following 16 weeks, and every four weeks thereafter.

Am I guaranteed to receive study drug?

Yes, all participants will receive RO6870810, but different groups will receive different doses. All participants in the combination arm will receive daratumumab and RO6870810, as described above.

How long will I be in the study?

If you qualify and choose to participate, your total length of time in the study, including the screening, dosing period(s), and follow-up periods, will be about 3 years.

This study includes four periods:

  • Screening: The screening period, begins after you sign the informed consent form. It includes an exam and lab tests to evaluate whether or not you qualify for the clinical trial. The screening period may last about 28 days and will end with notification of whether or not you are qualified for the clinical trial.
  • Treatment: If you are accepted into the trial and choose to participate, you will be treated with the study drug. Detailed information about the duration, dosing and testing procedures during the treatment period and end of treatment visit will be explained by the study doctor.
  • Safety Follow-up: Following the end of your participation in the study, you will have a follow-up visit to evaluate safety of the drug.
  • Long-term Follow-up: After the safety follow-up visit, you will be followed every 12 weeks for up to 1 year after last dose to evaluate your disease status, any treatments you receive after completion of the study and survival status. Also, your study doctor (or an appointed delegate) may contact you or your family or caregiver, or may access your medical records or publically available records, to determine your long-term health status. If you decide you no longer want to be contacted or allow access to your medical records for follow-up information, tell your study doctor.

You will be asked to continue with the study treatment for as long as your multiple myeloma does not get worse.

Site Visit Requirements

The first 21 day cycle of this trial requires seven (7) site visits. Future cycles will require three (3) site visits for each 21 day cycle.

Will I continue to receive the study drug after the study is over?

You will be eligible to receive the study drug (RO6870810) free of charge after you complete the study if all of the following conditions are met:

  • You have a life-threatening or severe medical condition and require continued study drug treatment for your well-being.
  • There are no appropriate alternative treatments available to you.
  • You and your doctor comply with and satisfy any legal or regulatory requirements that apply to you. 
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

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