POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
POMALYST® (pomalidomide) + dex + daratumumab (DPd): An approved triplet with POMALYST.1,2
For adult patients with RRMM who had received
REVLIMID® (lenalidomide)* and a PI.
DPd Trial Design.1,2
DPd was studied in an open-label trial (without a comparator arm) of 103 patients who received a prior proteasome inhibitor and REVLIMID. Patients were required to have calculated CrCl ≥45 mL/min/1.73 m2, AST/ALT ≤2.5x ULN, and total bilirubin ≤2 mg/dL. Patients received 16 mg/kg of dara as an intravenous infusion weekly (Weeks 1-8), every 2 weeks (Weeks 9-24), and every 4 weeks from Week 25 until disease progression in combination with 4 mg of POMALYST once daily orally on Days 1-21 of repeated 28-day cycles and 40 mg/week low-dose oral or intravenous dex.† On dara infusion days, 20 mg of the dex dose was given as a pre-infusion medication between 1 and 3 hours before dara and the remainder given the following day. For patients on a reduced dex dose, the entire 20-mg dose was given as a pre-infusion medication prior to dara.

†Reduced dose of 20 mg/week for patients >75 years or body mass index <18.5.
Information about DPd does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab full PI for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv.
POMALYST + dexamethasone + daratumumab Indication (DPd)
POMALYST + dexamethasone + daratumumab is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
CONTRAINDICATIONS FOR DARATUMUMAB
Daratumumab is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylactic reactions) to daratumumab or any of the components of the formulation.
WARNINGS AND PRECAUTIONS FOR DARATUMUMAB
- Infusion-Related Reactions: Daratumumab can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening and fatal outcomes have been reported. Interrupt daratumumab infusion for infusion-related reactions of any severity. Permanently discontinue the infusion in case of anaphylactic reactions or life-threatening infusion reactions and institute appropriate emergency care.
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THE MAJORITY OF PATIENTS STUDIED WERE REFRACTORY TO REVLIMID1,2
REVLIMID
bortezomib
both
Patients had received a median of 4 prior lines of therapy
- Prior therapies included: ASCT (74%), bortezomib (98%), and carfilzomib (33%); 98% were previously treated with the combination of bortezomib and lenalidomide1
- Median patient age was 64 years (range: 35-86)1
- The ECOG performance status was 0 in 27%, 1 in 61%, and 2 in 12% of patients2
- 87 out of 103 patients had available cytogenetic data: 18% were del17p, 7% were t(4;14), and 1% were t(14;16)2
*Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.
ALT, alanine aminotransferase; ASCT, autologous stem cell transplant; AST, aspartate aminotransferase; CrCl, creatinine clearance; dara, daratumumab; dex, dexamethasone; DPd, POMALYST + dexamethasone + daratumumab; ECOG, Eastern Cooperative Ecology Group; ORR, overall response rate; PI, proteasome inhibitor; RRMM, relapsed/refractory multiple myeloma; ULN, upper limit of normal.
References: 1. Daratumumab [package insert]. Horsham, PA: Janssen Biotech, Inc. 2. Chari A, Suvannasankha A, Fay JW, et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood. 2017;130(8):974-981.