Clinical Trial Goal
To find out if venetoclax, in combination with dexamethasone and isatuximab, is safe and works well to treat multiple myeloma that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have multiple myeloma that has relapsed or is refractory
- Have 11;14 translocation. Your doctor can tell you this
- Do not have any of the following:
- Amyloidosis
- Graft-versus-host-disease (GVHD)
- POEMS syndrome
- Have not been treated with any of the following:
- Anti-CD38 antibody
- Venetoclax
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Dexamethasone is a drug that reduces inflammation.
Isatuximab is a monoclonal antibody that targets CD38 on certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
Isatuximab is a monoclonal antibody that targets CD38 on certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Dexamethasone – Given as intravenous (IV) infusions 1 time each week
- Isatuximab – Given as IV infusions up to 1 time each week
- Venetoclax – A pill that you take by mouth 1 time each day
You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for 4.5 years.
The Food and Drug Administration (FDA) has approved isatuximab to treat multiple myeloma. Venetoclax is approved to treat acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Using venetoclax to treat multiple myeloma is new and unproven.
Contacts
Richard Bailey, (310) 464-2190, rbailey@oncotherapeutics.com
Yohana Sebhat, 310-810-3158, ysebhat@oncotherapeutics.com
Locations
Berenson Cancer CenterRECRUITING
West Hollywood, California
Contacts:
- Marceya Soto, 310-623-1218, msoto@berensoncancercenter.com
- Victor Tellez, 310-623-1218, vtellez@berensoncancercenter.com
Nebraska Cancer SpecialistsRECRUITING
Omaha, Nebraska
Ashley Servais, MPH, 402-955-2691, aservais@nebraskacancer.com
Sponsors
lead: Oncotherapeutics
