A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

Clinical Trial Details

The purpose of this study is to determine if the investigational therapy bb2121 is safe and effective in treating relapsed and refractory multiple myeloma compared to standard regimens.

The study treatment will be either bb2121 or a standard regimen. The choices of the regimens are as per the study doctor’s discretion and dependent on your prior anti-myeloma treatment regimens:

Daratumumab in combination with pomalidomide and dexamethasone (DPd)
Daratumumab in combination with bortezomib and dexamethasone (DVd)
Ixazomib in combination with lenalidomide and dexamethasone (IRd)
Carfilzomib in combination with low-dose dexamethasone (Kd)
Elotuzumab in combination with pomalidomide and low-dose dexamethasone (EPd)

bb2121 is a type of therapy known as chimeric antigen receptor (CAR) T cell therapy. T cells are a kind of white blood cell which form part of your body’s immune system. Your own T cells are not able to recognize multiple myeloma cells. bb2121 therapy involves modifying your own T cells so that they can recognize and destroy the multiple myeloma cells. bb2121 therapy involves modifying your own T cells so that they can recognize a protein called B-Cell Maturation Antigen (BCMA), which your multiple myeloma cells carry on their surface. The bb2121 T cells would then become activated to destroy the multiple myeloma cells. bb2121 therapy is not currently approved for the treatment of relapsed and refractory multiple myeloma and its use in this study is investigational.

In this study, some of your T cells will be collected from your blood in a procedure called leukapheresis. The collected cells will then be modified in a laboratory in the United States. In the laboratory, a new gene will be inserted into your T cells using a genetically modified virus. After approximately 4 to 5 weeks, the modified T cells, now called bb2121 T cells, will be infused back into your blood.

Key Eligibility:

Inclusion Criteria

Open to men and women ≥ 18 years of age who have been diagnosed with multiple myeloma
Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted
Subject is willing and able to adhere to the study visit schedule and other protocol requirements within this protocol and for a -subject randomized to Treatment Arm A, subject agrees to continued follow-up for up to 15 years as mandated by the -regulatory guidelines for gene therapy trials
Subject has documented diagnosis of MM and measurable disease

Exclusion Criteria

Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
Subject has any condition that confounds the ability to interpret data from the study
Subject has nonsecretory multiple myeloma (MM)

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

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Ashlee N. Torres, RN
(212) 746-7117
ant9105@med.cornell.edu

Primary Investigator(s)

Roger N Pearse, MD (UES)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1905020064

ClinicalTrials.gov:

NCT03651128

Status

Open to Enrollment

Age Group

Adult

Disease

Cancer

Hematologic Malignancies

Multiple Myeloma