DARZALEX® + Rd: Newly Diagnosed, Transplant-Ineligible MM1

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The MAIA trial regimen was DARZALEX® + Rd vs Rd alone

DARZALEX® + Revlimid® (lenalidomide) + dexamethasone

DARZALEX®+ Rd approval for adult patients with newly diagnosed, transplant-ineligible MM is based on a large, randomized, open-label, multicenter, active-controlled phase 3 trial1,2

BMI=body mass index; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); ECOG=Eastern Cooperative Oncology Group; IV=intravenous; MM=multiple myeloma; PD=progressive disease; PO=by mouth; QW=weekly; Q2W=every 2 weeks; Q4W=every 4 weeks; Rd=lenalidomide (R) + dexamethasone (d).

*On days when daratumumab was administered, dexamethasone was administered to patients in the DRd arm and served as the treatment dose of steroid for that day, as well as the required pre-infusion medication.1-3

For patients older than 75 years of age or with BMI <18.5, dexamethasone was administered at a dose of 20 mg weekly.1

Efficacy was evaluated by PFS based on International Myeloma Working Group (IMWG) criteria.1

Revlimid® is a registered trademark of Celgene Corporation.

Primary endpoint was progression-free survival (PFS). Key secondary endpoints included ≥ complete response (CR) rate, ≥ very good partial response (VGPR) rate, minimal residual disease (MRD) negative rate (NGS; 10-5), overall response rate (ORR), overall survival (OS), and safety.2

Baseline demographics and disease characteristics were similar between the two treatment groups.1,2

NGS=next-generation sequencing.

 

Patient Characteristics in the MAIA trial

Demographic, baseline disease, and clinical characteristics in the ITT population1

Patient characteristics Intent-to-treat population
(N=737)
Median age (range) – y 73 (45-90)
Sex Percent
Male 52
Race
White 92
ECOG status§
0 34
1 50
≥2 17
ISS stage
I 27
II 43
III 29

ISS=International Staging System; ITT=intent-to-treat.

§ECOG performance status is scored on a scale from 0 to 5, with 0 indicating no symptoms and higher scores indicating increased disability.2

Daratumumab (DARZALEX®) in combination with lenalidomide and dexamethasone is recommended by the NCCN® Guidelines as a preferred Category 1 therapeutic option for non-transplant candidates

Category 1=based upon high-level evidence, there is uniform National Comprehensive Cancer Network® (NCCN®) consensus that the intervention is appropriate.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Multiple Myeloma V.1.2020. © National Comprehensive Cancer Network, Inc. 2019. Accessed September 11, 2019. All rights reserved. To view the most recent and complete version of the guideline, go online to www.nccn.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.