Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma
Phase II Multicenter Trial of Anti-BCMA CAR T-Cell Therapy for MM Patients With Sub-Optimal Response After Auto HCT and Maintenance Len. BMTCTN1902
3 other identifiers
interventional
40
1 country
15
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 multiple-myeloma
Started Jan 2022
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedStudy Start
First participant enrolled
January 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2025
CompletedResults Posted
Study results publicly available
January 12, 2026
CompletedMarch 5, 2026
March 1, 2026
2.6 years
July 8, 2021
November 4, 2025
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of BCMA CAR-T Cell Therapy
Achieving a complete response or better (CR or sCR) as assessed by the 6-month time point after BCMA CAR T-cell therapy in MM patients with suboptimal disease responses after an autologous HCT and lenalidomide maintenance.
6 months
Secondary Outcomes (7)
Assessment of Disease Progression
1 Year
Best Disease Response
1 Year
Non Relapse Mortality
1 Year
Progression Free Survival
1 Year
Incidence of Cytokine Release Syndrome
1 year
- +2 more secondary outcomes
Other Outcomes (8)
Exploratory Objective 1: Incidence of Toxicities Greater Than or Equal to Grade 3 Per the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
1 Year
Exploratory Objective 2: Incidence of Infections Per Protocol-specific Manual of Procedures (MOP)
1 Year
Exploratory Objective 3: Maintenance Feasibility
1 Year
- +5 more other outcomes
Study Arms (1)
Lenalidomide and bb2121
EXPERIMENTALPatients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg 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 patient reaches 12 months post CAR T-cell infusion and continue free of progression.
Interventions
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
Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells.
300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion
30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion
Eligibility Criteria
You may qualify if:
- Age greater than or equal to 18.00 years
- Patients must meet the criteria for symptomatic MM requiring therapy (Appendix A) prior to initiating initial systemic anti-myeloma treatment.
- Patients must have received initial systemic anti- myeloma therapy consisting of induction therapy and consolidation with high-dose melphalan (\>140 mg/m\^2 ) followed by an auto HCT (minimum cell dose of 2x10\^6 CD34+ cells/kg (actual body weight) within 12 months from initiation of systemic anti-myeloma therapy.
- Patient must have additional stored stem cells greater than or equal to 2x10\^6 CD34+ cells per kg actual body weight.
- Patients must be less than or equal to 12 months after autologous HCT at the time of enrollment.
- Patients must have initiated maintenance therapy with lenalidomide-based regimen within 6 months after the auto HCT and have received at least 3 months of maintenance prior to enrollment.
- Patients must have tolerated a minimum dose of lenalidomide 5 mg/day for 21 days of a 28-day cycle for greater than 2 cycles without having to stop due to toxicities.
- Patients must have a VGPR or less (Section 3.1) in reference to time time of initiation of initial systemic anti-myeloma therapy at study enrollment.
- Patients must have Karnofsky performance greater than or equal to 70.
- Patients must have recovered to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding Grade 2 neuropathy.
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3 without filgrastim use in the prior 14 days.
- Platelet count greater than 100,000/mm\^3 (without platelet transfusion in the previous 7 days or thrombopoietin mimetics in the previous 28 days).
- Hemoglobin greater than 9 g/dL (without red blood cell transfusion in the previous 7 days).
- Creatinine Clearance (CrCl) greater than or equal to 60 mL/min, measured or estimated by Cockcroft-Gault equation.
- Corrected serum calcium less than or equal to 13.5 mg/dL.
- +7 more criteria
You may not qualify if:
- Patients with a prior allogeneic hematopoietic cell.
- Female of childbearing potential (FCBP) is a female who:
- has achieved menarche at some point,
- has not undergone a hysterectomy or bilateral oophorectomy or
- has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Patients with disease progression (see Section 3.1.2 for disease progression definition) at any time prior to enrollment.
- Patients receiving any of the following less than 14 days prior to enrollment:
- Plasmapheresis
- Major surgery (as defined by the investigator)
- Radiation therapy other than local therapy for MM-associated bone lesions
- Use of any systemic anti-myeloma drug therapy (with the exception of lenalidomide maintenance)
- Any investigational agents
- Corticosteroids (Physiologic replacement, topical, intranasal and inhaled steroids are permitted)
- Patients with known Central Nervous System (CNS) involvement with MM.
- Patients with a prior organ transplant requiring systemic immunosuppressive therapy.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Blood and Marrow Transplant Clinical Trials Networkcollaborator
- National Cancer Institute (NCI)collaborator
- National Marrow Donor Programcollaborator
- Celgene a wholly owned subsidiary of BMScollaborator
- Medical College of Wisconsinlead
Study Sites (15)
City of Hope National Medical Center
Duarte, California, 91010, United States
Stanford Hospital and Clinics
Palo Alto, California, 94305, United States
University of California, San Francisco
San Francisco, California, 94143, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Roswell Park Cancer Center
Buffalo, New York, 14203, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
University of Pennsylvania Hospital Center
Philadelphia, Pennsylvania, 19104, United States
Baylor College and Medicine
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam Mendizabal, PhD
- Organization
- The Emmes Company, LLC
Study Officials
- STUDY DIRECTOR
Marcelo C Pasquini, MD, MS
Medical College of Wisconsin
- PRINCIPAL INVESTIGATOR
Alfred Garfall, MD
University of Pennsylvannia
- PRINCIPAL INVESTIGATOR
Sergio Giralt, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2021
First Posted
September 2, 2021
Study Start
January 5, 2022
Primary Completion
August 22, 2024
Study Completion
February 20, 2025
Last Updated
March 5, 2026
Results First Posted
January 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Within 6 months of official study closure at participating sites
- Access Criteria
- Available to public
Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc., where indicated).