Relapsed and Refractory Multiple Myeloma
Conditions
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility is determined prior to leukapheresis. Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is >= 18 years of age at the time of signing the informed consent form (ICF). 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 4. 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 5. Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.
Exclusion criteria
Exclusion criteria: The 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 such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. (Note: this criterion does not apply to subjects undergoing retreatment unless Grade 4 neurotoxicity was observed following prior treatment with bb2121). 3. Subjects with active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis. 4. Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease. 5. Inadequate hepatic function defined by AST and/or ALT > 2.5 x upper limit of normal (ULN) and total bilirubin > 1.5 x ULN (unless due to Gilbert's syndrome and direct bilirubin is 1.5 x ULN, or history of Grade >=2 hemorrhage within 30 days, or subject requires ongoing treatment with chronic, therapeutic dosing of anti-coagulants (eg, warfarin, low molecular weight heparin, or Factor Xa inhibitors). 8. Inadequate bone marrow function defined by absolute neutrophil count (ANC) < 1000 cells/mm3 in the absence of growth factor support (filgrastim within 7 days or pegfilgrastim within 14 days of screening) and platelet count < 50,000 mm3 in the absence of transfusion support (platelet transfusion within 7 days of screening). 9. Echocardiogram or MUGA with left ventricular ejection fraction < 45%. 10. Inadequate pulmonary function as defined as oxygen saturation (Sa02) < 92 % on room air. 11. Ongoing treatment with chronic immunosuppressants (eg, cyclosporine or systemic steroids at any dose). Intermittent topical, inhaled or intranasal corticosteroids are allowed. 12. 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. 13. Evidence of human immunodeficiency virus (HIV) infection. 14. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) - Subjects who are hepatitis B surface antigen (HBsAg) negative and HBV viral DNA negative are eligible - Subjects who had hepatitis B but have received an antiviral treatment and show nondetectable viral DNA for 6 months are eligible - Subjects who are seropositive because of hepatitis B virus vaccine are eligible - Subjects with known HBV infection should have undetectable HBV viral load and be maintained on anti-viral therapy to prevent HBV reactivation. 15. Seropositive for and with active viral infection with hepatitis C virus (HCV) - Subjects who had hepatitis C but have received an antiviral treatment and show no detectable HCV viral RNA for 6 months are eligible. 16. Subjects with a history of class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months prior to starting study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy - Overall Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Efficacy Other - Complete Response (CR) Rate - Time to Response - Duration of Response (DOR) - Progression-free Survival (PFS) - Time to Progression (TTP) etc. | — |
Countries
Europe, Japan, North America
Contacts
Public ContactJin Hayakawa
Bristol-Myers Squibb
Outcome results
None listed