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.
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.
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 If you miss more than 4 doses during Cycle 1, you will be withdrawn from the study.
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.
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.
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:
You will be asked to continue with the study treatment for as long as your multiple myeloma does not get worse.
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.
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:
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.