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Study of bb2121 in Multiple Myeloma

Enrolling

Trial ID:NCT02658929

View complete trial on ClinicalTrials.gov

Protocol #:16-054

DiseasesMultiple Myeloma

Phase:Phase 1

Principal Investigator:Nikhil Munshi, MD

Site Investigator(s):Jacalyn Rosenblatt, MD
Noopur Raje, MD

Trial Description:
Study CRB-401 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb2121 in adults with relapsed/refractory multiple myeloma (MM).

Contacts:
Heidi DiPietro, RN, Dana-Farber Cancer Institute, 617-632-2570, hdipietro@partners.org
Cancer Trials Call Center, Beth-Israel Deaconess Medical Center, 617-667-3060
Cancer Trials Call Center, Massachusetts General Hospital, 877-789-6100
Kristen Cummings, RN, Dana-Farber Cancer Institute, 617-632-2570, kcummings2@partners.org

Conducting Institutions:
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Beth-Israel Deaconess Medical Center
Massachusetts General Hospital

Eligibilty Requirements:
Inclusion Criteria:

- ≥ 18 years of age at the time of signing informed consent

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor (e.g., bortezomib or carfilzomib) and immunomodulatory therapy (IMiD; e.g., lenalidomide or pomalidomide), or have "double refractory" disease to a proteasome inhibitor and IMiD, defined as progression on or within 60 days of treatment with these agents.

- Subjects must have measurable disease

- Women of child-bearing potential (WCBP) must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study

Exclusion Criteria:

- Subjects with known central nervous system disease

- Inadequate hepatic function

- Inadequate renal function

- Inadequate bone marrow function

- Presence of active infection within 72 hours

- Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control

- Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions

- Known human immunodeficiency virus (HIV) positivity

- Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control

- Pregnant or lactating women