Amyloid Light Chain Amyloidosis
Conditions
Brief summary
incidence of any toxicity grade of cardiac events, - C[trough]
Detailed description
Overall HemCR and HemCR rate at 6 months, Rate of VGPR or better, Time to HemCR (or VGPR or better), Duration of response (HemCR and VGPR or better), Organ response rate (OrRR) at 6 months and 12 months for kidney, heart, liver, Overall survival (OS), Time to next treatment (TNT), Incidence and severity of AEs, Pharmacokinetic profile of daratumumab, Immunogenicity of daratumumab and rHuPH20, Clinical signs and symptoms of cardiac AL amyloidosis
Interventions
DRUGCYCLOPHOSPHAMIDE
DRUGVELCADE 3.5 mg powder for solution for injection
DRUGDARATUMUMAB
DRUGDEXAMETHASONE SODIUM PHOSPHATE
Sponsors
Janssen - Cilag International
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of any toxicity grade of cardiac events, - C[trough] | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall HemCR and HemCR rate at 6 months, Rate of VGPR or better, Time to HemCR (or VGPR or better), Duration of response (HemCR and VGPR or better), Organ response rate (OrRR) at 6 months and 12 months for kidney, heart, liver, Overall survival (OS), Time to next treatment (TNT), Incidence and severity of AEs, Pharmacokinetic profile of daratumumab, Immunogenicity of daratumumab and rHuPH20, Clinical signs and symptoms of cardiac AL amyloidosis | — |
Countries
France, Germany, Greece, Italy, Netherlands, Spain
Outcome results
None listed