Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma

Summary

This study is designed as a Phase II, multicenter, single arm trial to assess anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve post autologous hematopoietic cell transplant (HCT) responses among patients with multiple myeloma (MM).

Conditions

• Multiple Myeloma

Interventions

DRUG

Lenalidomide

Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression

BIOLOGICAL

bb2121

Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells.

DRUG

Cyclophosphamide

300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion

DRUG

Fludarabine

30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion

PROCEDURE

leukapheresis

Placement of central line catheter and leukapheresis

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Blood and Marrow Transplant Clinical Trials Network

  collaborator NETWORK

• National Cancer Institute (NCI)

  collaborator NIH

• National Marrow Donor Program

  collaborator OTHER

• Celgene a wholly owned subsidiary of BMS

  collaborator UNKNOWN

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Marcelo C Pasquini, MD, MS · Medical College of Wisconsin

• Alfred Garfall, MD · University of Pennsylvannia

• Sergio Giralt, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-05

Primary Completion

2024-08-22

Completion

2025-02-20

FDA Drug

Yes

Countries

• United States

Study Locations