A Phase 2, open-label, randomized, dose optimization study evaluating the efficacy and safety of belantamab mafodotin administered in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed amyloid light chain amyloidosis (ALANIS)

Conditions

newly diagnosed amyloid light chain amyloidosis

Brief summary

Overall Complete Hematologic Response (CHR) rate, defined as the proportion of participants who achieve a CHR, according to the consensus guidelines for AL amyloidosis, during or after study treatment initiation.

Detailed description

Incidence of adverse events (AEs), Serious adverse event (SAEs), and clinically significant changes in laboratory parameters., Incidence, severity, duration and resolution of ocular findings on ophthalmic examination (corneal examination findings and changes in Best corrected visual acuity [BCVA])., Organ response rate (OrRR) for kidney, heart, and/or liver defined as the proportion of baseline organ involved participants who achieve confirmed organ response in each corresponding organ., Duration of CHR defined as the time between the date of initial documentation of CHR to the date of first documented evidence of hematologic progressive disease (PD)., Derived PK parameter (e.g., Cmax, AUC) values for belantamab mafodotin and Cysteine maleimidocaproyl monomethyl auristatin F (cys-mcMMAF), as data permit., Anti-drug antibody (ADA) incidence and summary titers of ADAs against belantamab mafodotin.

Related papers

No related papers found yet.

Interventions

DRUGFortecortin® 2 mg Tabletten

DRUGVELCADE 3.5 mg powder for solution for injection

DRUGENDOXAN 50 mg

DRUGcomprimé enrobé

DRUGDexamethason 8 mg GALEN® Tabletten

DRUGEndoxan®

DRUGBortezomib Hikma 3

DRUG5 mg Pulver zur Herstellung einer Injektionslösung

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Overall Complete Hematologic Response (CHR) rate, defined as the proportion of participants who achieve a CHR, according to the consensus guidelines for AL amyloidosis, during or after study treatment initiation.	—

Secondary

Measure	Time frame
Incidence of adverse events (AEs), Serious adverse event (SAEs), and clinically significant changes in laboratory parameters., Incidence, severity, duration and resolution of ocular findings on ophthalmic examination (corneal examination findings and changes in Best corrected visual acuity [BCVA])., Organ response rate (OrRR) for kidney, heart, and/or liver defined as the proportion of baseline organ involved participants who achieve confirmed organ response in each corresponding organ., Duration of CHR defined as the time between the date of initial documentation of CHR to the date of first documented evidence of hematologic progressive disease (PD)., Derived PK parameter (e.g., Cmax, AUC) values for belantamab mafodotin and Cysteine maleimidocaproyl monomethyl auristatin F (cys-mcMMAF), as data permit., Anti-drug antibody (ADA) incidence and summary titers of ADAs against belantamab mafodotin.	—

Measure

Time frame

Incidence of adverse events (AEs), Serious adverse event (SAEs), and clinically significant changes in laboratory parameters., Incidence, severity, duration and resolution of ocular findings on ophthalmic examination (corneal examination findings and changes in Best corrected visual acuity [BCVA])., Organ response rate (OrRR) for kidney, heart, and/or liver defined as the proportion of baseline organ involved participants who achieve confirmed organ response in each corresponding organ., Duration of CHR defined as the time between the date of initial documentation of CHR to the date of first documented evidence of hematologic progressive disease (PD)., Derived PK parameter (e.g., Cmax, AUC) values for belantamab mafodotin and Cysteine maleimidocaproyl monomethyl auristatin F (cys-mcMMAF), as data permit., Anti-drug antibody (ADA) incidence and summary titers of ADAs against belantamab mafodotin.

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Outcome results

None listed