Send to

Choose Destination
Blood. 2017 Aug 24;130(8):974-981. doi: 10.1182/blood-2017-05-785246. Epub 2017 Jun 21.

Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.

Author information

Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY.
Indiana University School of Medicine and Simon Cancer Center, Richard L. Roudebush VA Medical Center, Indianapolis, IN.
Baylor Institute for Immunology Research, Dallas, TX.
Unité d'Immuno-hématologie, Assistance Publique-Hôpitaux de Paris, Centre d'Investigations Cliniques 1427, Hôpital Saint Louis Lariboisière, Paris, France.
Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.
James P. Wilmot Cancer Center, University of Rochester Strong Memorial Hospital, Rochester, NY.
Abramson Cancer Center and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
The Judy and Bernard Briskin Myeloma Center, City of Hope, Duarte, CA.
Columbia University Medical Center, New York, NY.
Division of Hematology-Oncology, Tufts Medical Center, Boston, MA.
Janssen Research & Development, Raritan, NJ; and.
Janssen Research & Development, Spring House, PA.


Daratumumab plus pomalidomide and dexamethasone (pom-dex) was evaluated in patients with relapsed/refractory multiple myeloma with ≥2 prior lines of therapy who were refractory to their last treatment. Patients received daratumumab 16 mg/kg at the recommended dosing schedule, pomalidomide 4 mg daily for 21 days of each 28-day cycle, and dexamethasone 40 mg weekly. Safety was the primary end point. Overall response rate (ORR) and minimal residual disease (MRD) by next-generation sequencing were secondary end points. Patients (N = 103) received a median (range) of 4 (1-13) prior therapies; 76% received ≥3 prior therapies. The safety profile of daratumumab plus pom-dex was similar to that of pom-dex alone, with the exception of daratumumab-specific infusion-related reactions (50%) and a higher incidence of neutropenia, although without an increase in infection rate. Common grade ≥3 adverse events were neutropenia (78%), anemia (28%), and leukopenia (24%). ORR was 60% and was generally consistent across subgroups (58% in double-refractory patients). Among patients with a complete response or better, 29% were MRD negative at a threshold of 10-5 Among the 62 responders, median duration of response was not estimable (NE; 95% confidence interval [CI], 13.6-NE). At a median follow-up of 13.1 months, the median progression-free survival was 8.8 (95% CI, 4.6-15.4) months and median overall survival was 17.5 (95% CI, 13.3-NE) months. The estimated 12-month survival rate was 66% (95% CI, 55.6-74.8). Aside from increased neutropenia, the safety profile of daratumumab plus pom-dex was consistent with that of the individual therapies. Deep, durable responses were observed in heavily treated patients. The study was registered at as #NCT01998971.

[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Silverchair Information Systems Icon for PubMed Central
Loading ...
Support Center