This study is researching an experimental drug called linvoseltamab ("study drug"). This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again. The study consists of 2 phases (Phase 1 and Phase 2): * In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2. * In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long * How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long * What the right dosing regimen is for linvoseltamab * What side effects may happen from taking linvoseltamab * How much linvoseltamab is in the blood at different times * Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
anti-B-cell maturation antigen x anti-Cluster of differentiation 3 bispecific antibody
City of Hope
Duarte, California, United States
RECRUITINGColorado Blood Cancer Institute/SCRI
Denver, Colorado, United States
RECRUITINGKarmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGRoswell Park Comprehensive Cancer Center
Buffalo, New York, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITING...and 8 more locations
Incidence of dose-limiting toxicity (DLTs)
Phase 1
Time frame: Up to 28 Days
Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC)
Phase 2
Time frame: Up to 3 years
Achievement of hematologic CR, as determined by the IRC
Phase 1
Time frame: Up to 3 years
Achievement of hematologic very good partial response (VGPR) or better response (CR + VGPR), as determined by the IRC
Time frame: Up to 3 years
Achievement of overall hematologic response (PR or better), as determined by the IRC
Time frame: Up to 3 years
Time to initial hematologic response
Time frame: Up to 3 years
Time to best hematologic response
Time frame: Up to 3 years
Duration of hematologic response (ie, best response, VGPR or better, overall response), as determined by the IRC
Time frame: Up to 7 years
Hematologic progression-free survival (PFS)
Time frame: Up to 7 years
Incidence of death
Time frame: Up to 7 years
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 39 months
Severity of TEAEs
Time frame: Up to 39 months
Incidence of serious adverse events (SAEs)
Time frame: Up to 39 months
Severity of SAEs
Time frame: Up to 39 months
Incidence of adverse events of special interest (AESIs)
Time frame: Up to 39 months
Severity of AESIs
Time frame: Up to 39 months
Achievement of overall hematologic response (PR or better), as determined by the IRC in dose regimen 1 vs 2
Phase 2
Time frame: Up to 39 months
Incidence of TEAEs in dose regimen 1 vs 2
Phase 2
Time frame: Up to 39 months
Severity of TEAEs in dose regimen 1 vs 2
Phase 2
Time frame: Up to 39 months
Incidence of SAEs in dose regimen 1 vs 2
Phase 2
Time frame: Up to 39 months
Severity of SAEs in dose regimen 1 vs 2
Phase 2
Time frame: Up to 39 months
Incidence of AESIs in dose regimen 1 vs 2
Phase 2
Time frame: Up to 39 months
Severity of AESIs in dose regimen 1 vs 2
Phase 2
Time frame: Up to 39 months
Time from treatment initiation to hematologic disease progression as determined by the IRC
Time frame: Up to 7 years
Time from treatment initiation to cardiac deterioration, as determined by the IRC
Time frame: Up to 7 years
Time from treatment initiation to kidney deterioration as determined by the IRC
Time frame: Up to 7 years
Time from treatment initiation to death as determined by the IRC
Time frame: Up to 7 years
Time from initiation of treatment to date of death from any cause
Time frame: Up to 7 years
Achievement of renal response in participants with renal involvement at baseline, as determined by IRC
Time frame: Up to 7 years
Achievement of cardiac response in participants with cardiac involvement at baseline, as determined by IRC
Time frame: Up to 7 years
Time to first renal response in participants with renal involvement at baseline
Time frame: Up to 7 years
Time to first cardiac response in participants with cardiac involvement at baseline
Time frame: Up to 7 years
Linvoseltamab concentration in serum over time
Time frame: Up to 39 months
Incidence of anti-drug antibodies (ADAs) to linvoseltamab over time
Time frame: Up to 39 months
Titers of ADAs to linvoseltamab over time
Time frame: Up to 39 months
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