A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug.
The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.
The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.
Not Available
Phase III
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
Anitocabtagene Autoleucel,
Bortezomib (BTZ),
Carfilzomib (Kyprolis),
Daratumumab,
Dexamethasone,
Pomalidomide (POM)(CC-4047)
Biltibo, Eden
International
Vanderbilt University
06-23-2025
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Documented historical diagnosis of multiple myeloma (MM)
Documented historical diagnosis of multiple myeloma (MM)
Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.
Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.
Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen
Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen
Measurable disease at screening per IMWG, defined as any of the following: * Serum M-protein level 0.5 g/dL or urine M-protein level 200 mg/24 hours; or * Light chain MM without measurable disease in the serum or urine: serum free light chain 10 mg/dL and abnormal serum free light chain ratio
Measurable disease at screening per IMWG, defined as any of the following: * Serum M-protein level 0.5 g/dL or urine M-protein level 200 mg/24 hours; or * Light chain MM without measurable disease in the serum or urine: serum free light chain 10 mg/dL and abnormal serum free light chain ratio
Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study
Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
Exclusion Criteria:
Prior B-cell maturation antigen (BCMA)-targeted therapy
Prior B-cell maturation antigen (BCMA)-targeted therapy
Prior T-cell engager therapy
Prior T-cell engager therapy
Prior CAR therapy or other genetically modified T-cell therapy
Prior CAR therapy or other genetically modified T-cell therapy
Active or prior history of central nervous system (CNS) or meningeal involvement of MM
Active or prior history of central nervous system (CNS) or meningeal involvement of MM
Cardiac atrial or cardiac ventricular MM involvement
Cardiac atrial or cardiac ventricular MM involvement
History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted.
Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted.
Prior auto-SCT within 12 weeks before randomization
Prior auto-SCT within 12 weeks before randomization
Prior allogeneic stem cell transplant (allo-SCT)
Prior allogeneic stem cell transplant (allo-SCT)
High-dose (eg, cumulative > 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
High-dose (eg, cumulative > 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
Live vaccine 4 weeks before randomization
Live vaccine 4 weeks before randomization
Contraindication to fludarabine or cyclophosphamide
Contraindication to fludarabine or cyclophosphamide
History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.
History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.
Life expectancy 12 weeks
Life expectancy 12 weeks
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Documented historical diagnosis of multiple myeloma (MM)
Documented historical diagnosis of multiple myeloma (MM)
Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.
Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.
Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen
Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen
Measurable disease at screening per IMWG, defined as any of the following: * Serum M-protein level 0.5 g/dL or urine M-protein level 200 mg/24 hours; or * Light chain MM without measurable disease in the serum or urine: serum free light chain 10 mg/dL and abnormal serum free light chain ratio
Measurable disease at screening per IMWG, defined as any of the following: * Serum M-protein level 0.5 g/dL or urine M-protein level 200 mg/24 hours; or * Light chain MM without measurable disease in the serum or urine: serum free light chain 10 mg/dL and abnormal serum free light chain ratio
Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study
Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
Exclusion Criteria:
Prior B-cell maturation antigen (BCMA)-targeted therapy
Prior B-cell maturation antigen (BCMA)-targeted therapy
Prior T-cell engager therapy
Prior T-cell engager therapy
Prior CAR therapy or other genetically modified T-cell therapy
Prior CAR therapy or other genetically modified T-cell therapy
Active or prior history of central nervous system (CNS) or meningeal involvement of MM
Active or prior history of central nervous system (CNS) or meningeal involvement of MM
Cardiac atrial or cardiac ventricular MM involvement
Cardiac atrial or cardiac ventricular MM involvement
History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted.
Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted.
Prior auto-SCT within 12 weeks before randomization
Prior auto-SCT within 12 weeks before randomization
Prior allogeneic stem cell transplant (allo-SCT)
Prior allogeneic stem cell transplant (allo-SCT)
High-dose (eg, cumulative > 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
High-dose (eg, cumulative > 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
Live vaccine 4 weeks before randomization
Live vaccine 4 weeks before randomization
Contraindication to fludarabine or cyclophosphamide
Contraindication to fludarabine or cyclophosphamide
History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.
History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.
Life expectancy 12 weeks
Life expectancy 12 weeks
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
