POMALIDOMIDE + LOW-DOSE DEXAMETHASONE + DARATUMUMAB IN PATIENTS WITH RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA AFTER LENALIDOMIDE-BASED TREATMENT FAILURE
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 University of California,Los Angeles,United States
,
Christy Samaras
Affiliations:
Cleveland Clinic,Cleveland ,United States
,
Michael Sebag
Affiliations:
McGill University Health Centre,Montreal,Canada
,
Jesus Berdeja
Affiliations:
Sarah Cannon Research Institute,Nashville,United States
,
Siddharta Ganguly
Affiliations:
The University of Kansas Cancer Center,Fairway,United States
,
Jeffrey Matous
Affiliations:
Colorado Blood Cancer Institute,Denver,United States
,
Kevin Song
Affiliations:
Vancouver General Hospital,Vancouver ,Canada
,
Christopher S. Seet
Affiliations:
University of California, Los Angeles Medical Center,Los Angeles,United States
,
Giampaolo Talamo
Affiliations:
Penn State Hershey Cancer Institute,Hershey,United States
,
Shanti Srinivas
Affiliations:
Veterans Affairs New Jersey Health Care System,East Orange,United States
,
Mirelis Acosta-Rivera
Affiliations:
Fundación de Investigación,San Juan,Puerto Rico
,
Michael Bar
Affiliations:
Stamford Hospital,Stamford,United States
,
Donald Quick
Affiliations:
Joe Arrington Cancer Research and Treatment Center,Lubbock,United States
,
Bertrand Anz
Affiliations:
Tennessee Oncology,Chattanooga,United States
,
Gustavo Fonseca
Affiliations:
Florida Cancer Specialists,St. Petersburg,United States
,
Donna Reece
Affiliations:
Princess Margaret Cancer Centre,Toronto,Canada
,
Faiza Zafar
Affiliations:
Celgene Corporation,Summit,United States
,
Weiyuan Chung
Affiliations:
Celgene Corporation,Summit,United States
Nizar J. Bahlis
Affiliations:
University of Calgary,Calgary,Canada
EHA Library. S. Siegel D. 06/16/18; 215592; PS1292
David S. Siegel
David S. Siegel
Contributions
Abstract

Abstract: PS1292

Type: Poster Presentation

Presentation during EHA23: On Saturday, June 16, 2018 from 17:30 - 19:00

Location: Poster area

Background
MM-014 (NCT01946477) was designed to assess outcomes with pomalidomide (POM)-based treatment in patients with lenalidomide (LEN) treatment failure immediately before study entry. POM + low-dose dexamethasone (LoDEX) + daratumumab (DARA) was approved in the United States for use in patients with multiple myeloma (MM) who have received ≥ 2 prior therapies, including LEN and a proteasome inhibitor. However, data on the use of this triplet regimen in earlier lines of therapy and immediately after LEN-based treatment are limited. Cohort B of the MM-014 trial is investigating POM + LoDEX + DARA in this setting.

Aims
To present efficacy and safety analyses of cohort B of the MM-014 trial in which POM + LoDEX + DARA was given as second-line or greater treatment in patients with relapsed and/or refractory MM (RRMM).

Methods
Patients with RRMM who had received 1 or 2 prior lines of treatment, had a LEN-based treatment immediately before the study, and had progressive disease (PD) were eligible. In 28-day cycles, patients received POM 4 mg/day orally on days 1 to 21 + LoDEX 40 mg/day (20 mg/day if aged > 75 years) on days 1, 8, 15, and 22 + DARA 16 mg/kg intravenously on the LoDEX dosing days of cycles 1 and 2, then days 1 and 15 of cycles 3 to 6, then day 1 of cycles 7 onward. Thromboprophylaxis was mandatory. The primary objective was overall response rate (ORR) by modified International Myeloma Working Group criteria. All patients provided informed consent.

Results
The intention-to-treat population (ITT) included 46 patients. The median follow-up was 7.8 months; 13 patients discontinued treatment because of PD (n = 7), adverse events (n = 2), or other reasons (n = 4). Patients were refractory to (n = 36 [78%]) or had relapsed after (n = 10 [22%]) LEN-based treatment. The median duration of prior LEN-based treatment was 23.6 months, and 20 patients (43%) received LEN 25 mg/day as their last LEN-based treatment. Efficacy outcomes in the ITT population and grade 3/4 treatment-emergent adverse events in the safety population (n = 46; defined as all patients who received ≥ 1 dose of study drug) are shown in the table. The ORR was 76.7% in the efficacy-evaluable population (n = 43; defined as all patients who received ≥ 1 dose of study drug and had ≥ 1 post-baseline assessment for response), 72.2% in LEN-refractory patients, and 75.0% in patients who received LEN 25 mg/day as their last LEN-based treatment. Clinical benefit (defined as complete response, very good partial response, partial response, or minimal response) was achieved in 78.3% of patients, and the 1-year progression-free survival rate was 76.9%. At baseline, 10 patients (21.7%) had grade ≥ 2 neutropenia. Grade 3/4 pulmonary embolism and peripheral neuropathy occurred in 1 patient each. Any-grade infusion-related reactions occurred in 13 patients. The primary reasons for dose interruptions were neutropenia (POM and DARA) and infusion-related reactions (DARA only).

Conclusion
These results indicate that POM + LoDEX + DARA is an effective and tolerable regimen when sequenced in earlier lines of therapy in patients with RRMM and in whom first- or second-line therapy with a LEN-based treatment failed.

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

Keyword(s): Multiple Myeloma, Refractory, Relapse

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