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

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Unknown Primary	NCT ID:	NCT05250973
Trial Phases:	Phase II	Protocol IDs:	CR109160 (primary) NCI-2022-01987 2021-002639-48 54767414AMY2009
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT05250973

Summary

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).

Objectives

AL amyloidosis is a rare disorder caused by clonal plasma cells that secrete immunoglobulin
light chains that misfold into insoluble amyloid. The insoluble amyloid gets deposited in
vital organs which results in serious and life-threatening organ dysfunction. Daratumumab is
a human immunoglobulin (IgG1K) monoclonal antibody (mAb) that binds with high affinity to a
unique epitope on cluster of differentiation 38 (CD38), a transmembrane glycoprotein. It is a
targeted immunotherapy directed towards tumor cells that overexpress CD38. Participants will
be enrolled into 2 cohorts based on cardiac involvement at baseline for cohort 1 and racial
or ethnic minority with at least one organ involved for cohort 2. This study aims to generate
data on risk factors for cardiac toxicity and to evaluate the cardiac safety of the proposed
treatment regimens and identify potential mitigation strategies for cardiac toxicity such as
deferred VCd treatment, The study will consist of screening phase (up to 28 days) and
treatment phase with up to 24 treatment cycles (each cycle is 28 days). Safety assessment
will include adverse events (AEs), serious adverse events (SAEs), physical examinations,
Eastern Cooperative Oncology Group (ECOG) criteria for performance status, laboratory tests
and vital signs. The overall duration of the study will be up to 3 years and 8 months.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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