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A Phase 1b/2 Study of BGB-11417 as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

Clinical Trial Details

This clinical trial is for men and women who have Multiple Myeloma that is either unresponsive to prior treatment or has relapsed.
   
The purpose of this study is to examine the safety and effectiveness of an investigational drug currently known as sonrotoclax (BGB-11417) as monotherapy and combination therapy when given together with a drug called dexamethasone or when given together with dexamethasone and carfilzomib, dexamethasone and daratumumab or dexamethasone and pomalidomide in patients with relapsed/refractory (R/R) multiple myeloma (MM).
   
This study has multiple parts and cohorts (groups). Participants will either be placed in cohorts that involve sonrotoclax (BGB-11417) as monotherapy or combination therapy with dexamethasone or dexamethasone/carfilzomib; OR participants will be placed in cohorts that involve sonrotoclax (BGB-11417) as combination therapy with dexamethasone/daratumumab or dexamethasone/pomalidomide.
   
Sonrotoclax is an investigational drug, meaning it has not been approved for treatment by the U.S. Food and Drug Administration (FDA) in the United States.
   
Dexamethasone is a type of corticosteroid and one of the most frequently used medications in the treatment of multiple myeloma in combination with anti-cancer drugs such as carfilzomib and pomalidomide.
   
Carfilzomib belongs to a group of drugs known as proteasome inhibitors and is approved for the treatment of multiple myeloma in all the countries/regions participating in this study. The use of dexamethasone and/or carfilzomib in combination with sonrotoclax is considered investigational.
   
Daratumumab is a type of targeted cancer drug called a monoclonal antibody (MAB). It works by targeting a certain protein (called CD38) on myeloma cells so your immune system can recognize them. The immune system can then attack and kill the myeloma cells.
   
Pomalidomide is a targeted cancer drug and works in a number of ways, including: stopping the myeloma cells from developing; stopping blood vessel growth that helps cancer cells grow and survive; and encouraging the immune system to kill the myeloma cell. The use of dexamethasone/daratumumab or dexamethasone/pomalidomide in combination with sonrotoclax is considered investigational.
   
Sonrotoclax is given as an oral tablet taken daily with water. Dexamethasone may be given in oral tablet form or intravenous (IV) injection into the vein over 3 minutes. Carfilzomib is given as an up to 30-minute intravenous (IV) infusion into the vein. Daratumumab is given as a subcutaneous injection over approximately 3 to 5 minutes. Pomalidomide is given as an oral tablet taken with water.
   
For participants receiving sonrotoclax as monotherapy or in combination with dexamethasone, study treatment cycles will be three weeks, and there will be a visit each week. For participants receiving sonrotoclax, dexamethasone and carfilzomib, study treatment cycles will be four weeks long, and there will be a visit scheduled every week.
   
For participants receiving sonrotoclax, dexamethasone and daratumumab or pomalidomide, study treatment cycles will be four weeks long, and there will be a visit scheduled every week. 
   
The estimated length of the study is 3.5 years, but participants’ time on the study might differ based on how they respond to the study drug. Participants may continue study treatment as long as they are deriving some benefit from it for the disease and they do not experience intolerable side effects.

Key Eligibility: 
  1. Adults with a confirmed diagnosis of multiple myeloma.
  2. Patient has documented relapsed or progressive multiple myeloma on or after any regimen or who are refractory to the most recent line of therapy.

Detailed eligibility will be reviewed when participants contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Natalie Agudo, RN
646-962-5060
naa9101@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2404027278

ClinicalTrials.gov:

NCT04973605

Sponsor:

BGB-11417-105

Status

Open to Enrollment

Age Group

Adult

Sponsor