A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis

Running, not enrolling · Phase 2

Conditions studied: Amyloidosis

In brief

The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2).

Key facts

Study ID

NCT05250973

Run by

Janssen Research & Development, LLC

People needed

151

Starts

2022-03-01

Expected to finish

2026-10-26

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cohort 1: Cardiac involvement (amyloid light chain [AL] amyloidosis Mayo Cardiac Stage II and Stage IIIa) with or without other organ(s) involved; Cohort 2: One or more organs impacted by systemic AL amyloidosis according to consensus guidelines
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
• A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
• A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of cyclophosphamide or 100 days after discontinuation of daratumumab, whichever is longer
• Cohort 2 only: self-identified racial and ethnic minorities, including Black or African American
• Measurable disease at screening defined by one of the following:
• Difference between iFLC and uninvolved FLC (dFLC) >= 40mg/L per central laboratory Serum involved free light chain (iFLC) >= 40 mg/L with an abnormal kappa:lambda ratio Serum M-protein >= 0.5 g/dL

You may not qualify if…

• Prior therapy for systemic AL amyloidosis or multiple myeloma including medications that target cluster of differentiation 38 (CD38), with the exception of 160 milligrams(mg) dexamethasone or equivalent corticosteroid maximum exposure prior to randomization/enrollment
• Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, >=60% plasma cells in the bone marrow, or hypercalcemia related to myeloma.
• Participant received any of the following therapies:
• treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is less;
• vaccinated with an investigational vaccine (except for COVID-19) live, attenuated or replicating viral vector vaccines less than (<) 4 weeks prior to randomization/enrollment. Participants who are taking strong Cytochrome P450 3A4(CYP3A4) inducers must discontinue their use at least 5 half-lives prior to the first dose of bortezomib
• Stem cell transplantation -Planned stem cell transplant during the first 9 cycles of protocol therapy are excluded. Stem cell collection during the first 9 cycles of protocol therapy is permitted
• Grade 2 sensory or Grade 1 painful peripheral neuropathy

Where it is running

• City of Hope — Duarte, California, United States
• Yale — New Haven, Connecticut, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Institute Emory University — Atlanta, Georgia, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Memorial Sloan Kettering — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Wake Forest University - Baptist Medical Center — Winston-Salem, North Carolina, United States
• University Hospital of Cleveland — Cleveland, Ohio, United States
• Ohio Health Research Institute — Columbus, Ohio, United States
• West Penn Hospital — Pittsburgh, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• VCU Medical Center — Richmond, Virginia, United States
• University of Washington — Seattle, Washington, United States
• Tom Baker Cancer Center — Calgary, Alberta, Canada
• Cross Cancer Institute — Edmonton, Alberta, Canada
• University Health Network UHN Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Peking University First Hospital — Beijing, China
• Peking University People's Hospital — Beijing, China
• West China Hospital Si Chuan University — Chengdu, China
• First affiliated Hospital of Zhejiang University — Hangzhou, China
• Ruijin Hospital Shanghai Jiao Tong University — Shanghai, China
• CHU de Limoges — Limoges, France

Full record on ClinicalTrials.gov

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