SAFETY AND EFFICACY OF POMALIDOMIDE + LOW-DOSE DEXAMETHASONE IMMEDIATELY FOLLOWING LENALIDOMIDE-BASED TREATMENT FAILURE IN PATIENTS WITH RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA
Author(s): ,
David S. Siegel
Affiliations:
John Theurer Cancer Center, Hackensack University Medical Center,Hackensack,United States
,
Gary J. Schiller
Affiliations:
David Geffen School of Medicine at UCLA,Los Angeles,United States
,
Kevin Song
Affiliations:
Vancouver General Hospital,Vancouver,Canada
,
Richy Agajanian
Affiliations:
The Oncology Institute of Hope and Innovation,Downey,United States
,
Keith Stockerl-Goldstein
Affiliations:
Washington University School of Medicine,St. Louis,United States
,
Hakan Kaya
Affiliations:
Cancer Care Northwest,Spokane,United States
,
Michael Sebag
Affiliations:
McGill University Health Centre,Montreal,Canada
,
Christy Samaras
Affiliations:
Cleveland Clinic,Cleveland,United States
,
Ehsan Malek
Affiliations:
University Hospitals Case Medical Center,Cleveland,United States
,
Giampaolo Talamo
Affiliations:
Penn State Hershey Cancer Institute,Hershey,United States
,
Christopher S. Seet
Affiliations:
UCLA Medical Center,Los Angeles,United States
,
Jorge Mouro
Affiliations:
Celgene Corporation,Summit,United States
,
Faiza Zafar
Affiliations:
Celgene Corporation,Summit,United States
,
Weiyuan Chung
Affiliations:
Celgene Corporation,Summit,United States
,
Shankar Srinivasan
Affiliations:
Celgene Corporation,Summit,United States
,
Max Qian
Affiliations:
Celgene Corporation,Summit,United States
,
Amit Agarwal
Affiliations:
Celgene Corporation,Summit,United States
,
Anjan Thakurta
Affiliations:
Celgene Corporation,Summit,United States
Nizar J. Bahlis
Affiliations:
University of Calgary,Calgary,Canada
EHA Library. S. Siegel D. 06/15/18; 215017; PF567
David S. Siegel
David S. Siegel
Contributions
Abstract

Abstract: PF567

Type: Poster Presentation

Presentation during EHA23: On Friday, June 15, 2018 from 17:30 - 19:00

Location: Poster area

Background
Pomalidomide (POM) + low-dose dexamethasone (LoDEX) is a standard of care for the treatment (Tx) of patients (pts) with relapsed and/or refractory multiple myeloma (RRMM). This regimen is being investigated in the MM-014 (NCT01946477) trial as a third-line Tx in pts with RRMM in whom last prior therapy with lenalidomide (LEN) failed (cohort A). As LEN becomes increasingly established in earlier lines of Tx, it is pertinent to demonstrate efficacy in pts who have exhausted the benefit of LEN as their last Tx.

Aims
To present safety and efficacy results of POM + LoDEX as a third-line Tx immediately after LEN in cohort A of the MM-014 trial, including a subset analysis of pts who were previously treated with proteasome inhibitors (PI) and/or bortezomib (BORT).

Methods
Eligibility criteria included age ≥ 18 y, documented MM, 2 prior Tx lines, and progressive disease (PD) after ≥ 2 cycles of second-line LEN-based therapy. Pts received 28-d cycles of POM 4 mg/d on d 1-21 + LoDEX 40 mg/d (20 mg/d if > 75 y) on d 1, 8, 15, and 22, with mandatory thromboprophylaxis. The primary endpoint was overall response rate (≥ partial response per modified International Myeloma Working Group criteria). The clinical benefit rate was defined as the percentage of pts achieving complete response, very good partial response, partial response, or minimal response. Key secondary endpoints included progression-free survival (PFS), safety, and second primary malignancies (SPMs). All pts provided informed consent.

Results
A total of 56 pts were enrolled in cohort A. Median age was 68 y, with 62.5% of patients aged > 65 y in the intention-to-treat (ITT) population (prior PI, 63.4% [n = 41]; prior BORT, 64.1% [n = 39]) and 57.1% overall (prior PI, 58.5%; prior BORT, 56.4%) were male. Most pts had an ECOG performance status of 0/1: 92.9%, 95.1%, and 94.9%, respectively. All pts were refractory or relapsed to their most recent LEN-containing regimen, and 91.1%, 92.7%, and 92.3% of pts were LEN refractory, respectively. A majority of patients had prior stem cell transplant: 64.3% overall, 63.4% with prior PI, and 61.5% with prior BORT. Cytogenetic data by FISH were available for 50 pts: 4 were positive for del(17p), 4 for t(4;14), and 2 for t(14;16). Median duration of prior LEN-containing Tx was 23.6 mos (range, 3.5-107.0 mos), and in 60.7% of pts, the most recent LEN dose was 25 mg/d. Median follow-up was 19.0 mos at the data cutoff (10/2/2017). Responses and PFS outcomes are reported in the table. Of the 56 pts in the ITT population, 52 discontinued Tx, 31 (59.6%) due to PD, 7 withdrawal, 5 adverse events (AEs), 3 lack of efficacy, 2 death, and 3 other reasons. The most common grade 3/4 treatment-emergent AEs included anemia (25.0%), neutropenia (10.7%), fatigue (14.3%), and infections (25.0%, including pneumonia [14.3%]). Grade 3/4 pulmonary embolism was reported in 2 pts, and 1 pt had an SPM. Similar safety results were noted in pts with prior exposure to PI or BORT.

Conclusion
POM + LoDEX is a safe and effective third-line Tx for pts with RRMM following second-line failure of LEN-based Tx, including pts with prior exposure to PI or BORT. All pts, including those with prior PI or BORT Tx, experienced lower rates of hematologic AEs and longer median PFS than what has been previously reported for other studies using POM + LoDEX in later lines of Tx.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Multiple Myeloma, Refractory, Relapse

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