Amyloidosis

First Line:

IRB #H-39485/ Caelum Bio #CAEL-101 301: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis

IRB #H-40375/ Caelum Bio #CAEL-101 302: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis

First or Second Line:

IRB #H-35835/ Evomela: A Phase II Single-Center, Open-Label, Safety and Efficacy Study of Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients Undergoing Autologous Stem Cell Transplantation

Second Line:

Central IRB #H-36982/ Oncopeptides AB #OP201: An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy (temporary closure)

WIRB #H-40919/ Sorrento #STI-6129-001: A Phase 1, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients with Relapsed or Refractory Systemic AL Amyloidosis (pending)

IRB #H-39705/ Cornell Rosenbaum DPd: Daratumumab, Pomalidomide and Dexamethasone (DPd) in Relapsed/ Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab (pending)