Multiple Myeloma Clinical Trial

Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

Summary

This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

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Full Description

Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured.

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Eligibility Criteria

Inclusion Criteria:

Eligibility is determined prior to leukapheresis. Subjects must satisfy the following criteria to be enrolled in the study:

Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).

Documented diagnosis of multiple myeloma

Must have received at least 3 prior MM treatment regimens. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen.
Must have undergone at least 2 consecutive cycles of treatment for each regimen, unless PD was the best response to the regimen.
Must have received a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
Must be refractory to the last treatment regimen.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Subjects must have measurable disease, including at least one of the criteria below:

Serum M-protein greater or equal to 1.0 g/dL
Urine M-protein greater or equal to 200 mg/24 h
Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal
Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

Subjects with known central nervous system involvement with myeloma.
History or presence of clinically relevant central nervous system (CNS) pathology.
Subjects with active or history of plasma cell leukemia.
Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease
Inadequate organ function
Ongoing treatment with chronic immunosuppressants
Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy
Evidence of human immunodeficiency virus (HIV) infection.
Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV)
Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) and Hepatitis C virus (HCV)
Subjects with a history of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months.
Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission
Pregnant or lactating women.
Subject with known hypersensitivity to any component of bb2121 productThe presence of any of the following will exclude a subject from enrollment:

1. Subjects with known central nervous system involvement with myeloma. 2. History or presence of clinically relevant central nervous system (CNS) pathology.

3. Subjects with active or history of plasma cell leukemia. 4. Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease 5. Inadequate organ function 6. Ongoing treatment with chronic immunosuppressants 7. Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy 8. Evidence of human immunodeficiency virus (HIV) infection. 9. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) and Hepatitis C virus (HCV) 10. Subjects with a history of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months. 11. Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission 12. Pregnant or lactating women. 13 Subject with known hypersensitivity to any component of bb2121 product, cyclophosphamide, fludarabine, or tocilizumab.

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

149

Study ID:

NCT03361748

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 28 Locations for this study

See Locations Near You

Local Institution - 108
San Francisco California, 94143, United States
University of California - San Francisco
San Francisco California, 94143, United States
Emory University
Atlanta Georgia, 30322, United States
Local Institution - 103
Atlanta Georgia, 30322, United States
Local Institution - 107
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Massachusetts General Hospital
Boston Massachusetts, 02214, United States
Local Institution - 106
Boston Massachusetts, 02215, United States
Local Institution - 105
Rochester Minnesota, 55905, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Local Institution - 102
Hackensack New Jersey, 07601, United States
Local Institution - 109
New York New York, 10029, United States
Mt. Sinai Medical Center
New York New York, 10029, United States
Local Institution - 101
Nashville Tennessee, 37203, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Local Institution - 104
Dallas Texas, 75390, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Universitaire Ziekenhuizen Leuven
Leuven Flemish Brabant, 3000, Belgium
Local Institution - 201
Leuven , B-300, Belgium
Local Institution - 301
Toronto Ontario, M5G 2, Canada
Princess Margaret Cancer Centre
Toronto , M5G 2, Canada
Centre Hospitalier Regional Universitaire de Lille-Hopital Calude Huriez Service des Maladies du Sang
Lille Hauts-de-France, 59037, France
Centre Hospitalier Universitaire de Nantes - Hotel Dieu
Nantes Pays De La Loire, 44093, France
Local Institution - 402
Lille , 59037, France
Local Institution - 401
Nantes , 44093, France
Universitatsklinikum Heidelberg Medizinische Klinik Krehl-Klinik Haematologie, Onkologie, Rheumato
Heidelberg Baden-Württemberg, 69120, Germany
University of Tübingen
Tübingen Baden-Württemberg, 72076, Germany
Universitatsklinikum Würzburg
Würzburg Bavaria, 97080, Germany
Local Institution - 502
Heidelberg , 69120, Germany
Local Institution - 503
Tübingen , 72076, Germany
Local Institution - 501
Würzburg , 97080, Germany
Azienda Ospedaliero Universitaria Di Bologna Policlinico
Bologna Emilia-Romagna, 40138, Italy
Local Institution - 602
Bergamo , 24128, Italy
Ospedali Riuniti di Bergamo
Bergamo , 24128, Italy
Local Institution - 601
Bologna , 40138, Italy
Tokai University Hospital
Isehara Kanagawa, 259-1, Japan
Jichi Medical University Hospital
Shimotsuke Tochigi, 32904, Japan
Japan Red Cross Medical Center
Shibuya-ku Tokyo, 150-8, Japan
Local Institution - 803
Isehara City, Kanagawa , 259-1, Japan
Local Institution - 801
Shibuya-ku , 150-8, Japan
Local Institution - 802
Shimotsuke , 329-0, Japan
Local Institution - 804
Shinjuku City , 162-8, Japan
Tokyo Women's Medical University Hospital
Shinjuku City , 162-8, Japan
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona Barcelona, 08916, Spain
Clinica Universidad de Navarra
Pamplona Navarre, 31008, Spain
Local Institution - 702
Badalona (Barcelona) , 08916, Spain
Local Institution - 701
Pamplona , 31008, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

149

Study ID:

NCT03361748

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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