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2018 ASCO Annual Meeting!


Session: Hematologic Malignancies—Plasma Cell Dyscrasia

Type: Poster Session

Time: Monday June 4, 8:00 AM to 11:30 AM

Location: Hall A


Session: Hematologic Malignancies—Plasma Cell Dyscrasia

Type: Poster Discussion Session

Time: Monday June 4, 3:00 PM to 4:15 PM

Location: E450

Subcutaneous daratumumab (DARA SC) plus cyclophosphamide, bortezomib, and dexamethasone (CyBorD) in patients (Pts) with newly diagnosed amyloid light chain (AL) amyloidosis: Safety run-in results of andromeda.

Sub-category:
Plasma Cell Disorders

Category:
Hematologic Malignancies—Plasma Cell Dyscrasia

Meeting:
2018 ASCO Annual Meeting

Abstract No:
8011

Poster Board Number:
Poster Discussion Session (Board #20)

Citation:
J Clin Oncol 36, 2018 (suppl; abstr 8011)

Author(s): Ray Comenzo, Efstathios Kastritis, Mathew Maurer, Jeffrey A. Zonder, Monique Minnema, Stefan Schönland, Ashutosh Wechalekar, Giovanni Palladini, Xiang Qin, Sandra Y. Vasey, Imran Khan, Jordan Mark Schecter, Giampaolo Merlini; Division of Hematology/Oncology, John C. Davis Myeloma and Amyloid Program, Tufts Medical Center, Boston, MA; University of Athens School of Medicine, Alexandra General Hospital, Athens, Greece; Presbyterian Hospital and Vanderbilt Clinic, New York, NY; Barbara Ann Karmanos Cancer Research Institute, Detroit, MI; Department of Hematology, UMC Utrecht Cancer Center, Utrecht, Netherlands; Heidelberg University Hospital, Heidelberg, Germany; University College London and the Royal Free London NHS Foundation Trust, London, United Kingdom; Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, and Department of Molecular Medicine, University of Pavia, Pavia, Italy; Janssen Research & Development, LLC, Spring House, PA; Janssen Research & Development, LLC, Raritan, NJ; Scientific Institute Policlinico San Matteo, University of Pavia, Pavia, Italy

Abstract Disclosures

Abstract:

Background: Systemic AL amyloidosis is characterized by disposition of insoluble amyloid fibrils into tissues and organs via clonal expansion of CD38+ plasma cells. The safety run-in of DARA SC + CyBorD in ANDROMEDA (NCT03201965) is presented. Methods: Eligible pts had ≥1 involved organs, ECOG score ≤2, absolute neutrophil count ≥1.0 × 109/L; hemoglobin ≥8.0 g/dL; platelet count ≥50 × 109/L; estimated glomerular filtration rate ≥20 mL/min/1.73m2, and NT-ProBNP ≤8,500 ng/L. In the safety run-in, pts received a concentrated co-formulation of DARA (1,800 mg in 15 mL) and recombinant human hyaluronidase enzyme (rHuPH20; 30,000 U) in a single, pre-mixed vial, given by manual SC injection qw in Cycles 1-2, q2w in Cycles 3-6, and q4w thereafter ≤2 y. Cy 300 mg/m2 PO or IV and Bor 1.3 mg/m2 SC were given on Days 1, 8, 15, 22 of each 28-day cycle for ≤6 cycles and D 40 mg was given qw. Dosing was staggered ≥48 hours between pts to assess infusion related reactions (IRRs). Safety was evaluated after ≥10 pts received ≥1 treatment cycle. Results: Pts (n = 15) had a median (range) age of 63 (35-77) y and a median of 58 (15-157) d from diagnosis. Pts had a median of 1 (1-3) involved organ, with kidney involvement affecting 67% of pts and 40% of pts with ≥2 organs involved. At baseline, 73% and 27% of pts were grouped into New York Heart Association class I and II, respectively, and 93% of pts had an ECOG score of ≤1. Pts received a median of 2 (1-4) treatment cycles and a median of 5 (1-10) DARA injections. Most common ( > 2 pts) treatment emergent adverse events (TEAEs) were nausea (47%), diarrhea (33%), fatigue (33%), injection site erythema (20%), anemia (20%), and rash (20%). Dyspnea and peripheral edema were reported in 1 (7%) pt each. One grade 3/4 TEAE (hypertension; unrelated to treatment) and no serious TEAEs occurred. IRRs occurred in 2 (13.3%) pts (all grade 1). Additional data will be presented. Conclusions: DARA-CyBorD is tolerable in pts with AL amyloidosis with a low IRR rate and no new safety signals. The limited incidence of dyspnea and peripheral edema indicate a low risk for volume overload. Randomization into ANDROMEDA has begun. Clinical trial information: NCT03201965

 
Other Abstracts in this Sub-Category:

 

1. Randomized phase 3 trial of ibrutinib/rituximab vs placebo/rituximab in Waldenström's macroglobulinemia.

Meeting: 2018 ASCO Annual Meeting Abstract No: 8003 First Author: Meletios A. Dimopoulos
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Plasma Cell Disorders

 

2. Daratumumab-based therapies in patients with AL amyloidosis.

Meeting: 2018 ASCO Annual Meeting Abstract No: 8053 First Author: Jithma P. Abeykoon
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Plasma Cell Disorders

 

3. Characteristics and outcomes of primary plasma cell leukemia in the era of novel agents: Single center experience.

Meeting: 2018 ASCO Annual Meeting Abstract No: 8054 First Author: Iman Aboudalle
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Plasma Cell Disorders

 

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