ALCYONE: STUDY DESIGN & PATIENT CHARACTERISTICS

The ALCYONE Trial: DARZALEX® + VMP in Transplant-Ineligible Newly Diagnosed Multiple Myeloma

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DARZALEX® + Velcade® (bortezomib) + melphalan + prednisone

DARZALEX® approval for NDMM transplant-ineligible patients is based on a large, randomized, open-label, multicenter, active-controlled phase 3 trial1,2

 

Newly diagnosed multiple myeloma patients ineligible for autologous SCT (n=706)
Randomized 1:1
DARZALEX® + VMP
(n=350)
VMP
(n=356)
DARZALEX® 16 mg/kg once weekly for 6 weeks (Cycle 1) then every 3 weeks (Cycles 2–9) + VMP
  VMP up to 9 cycles  
DARZALEX® treatment continued every 4 weeks from week 55 onward, until disease progression or unacceptable toxicity
  • Treatment with VMP has previously been established as an effective therapy for patients with NDMM who are ineligible for stem-cell transplant in several trials2-4
  • Patients in the DARZALEX® + VMP arm received 16 mg/kg DARZALEX® until disease progression or unacceptable toxicity1
  • Participants received bortezomib 1.3 mg/m2 as subcutaneous injection, twice weekly at Weeks 1, 2, 4, and 5 (Cycle 1) followed by once weekly at Weeks 1, 2, 4, and 5 (Cycles 2-9); melphalan 9 mg/m2 and prednisone 60 mg/m2 were orally administered on Days 1 to 4 of the nine 6-week cycles (Cycles 1-9). Per protocol, VMP treatment was discontinued in both arms after 9 cycles1*
  • Primary endpoint was efficacy evaluated by progression-free survival (PFS) based on International Myeloma Working Group (IMWG) criteria1,2
  • Key secondary endpoints included overall response rate (ORR), rates of very good partial response (VGPR) or better, complete response (CR) or better, negative status for minimal residual disease (MRD), and overall survival (OS)2
    • Additional endpoints included time to response, duration of response, safety, and side effect profile2

NDMM=newly diagnosed multiple myeloma; SCT=stem cell transplant.

* Prednisone was withheld on Day 1 of each cycle when dexamethasone was used as premedication to reduce the risk of infusion reactions.

 

Patient Characteristics

Baseline demographics were similar between arms1,2,5

Patient characteristics DARZALEX® + VMP
(n=350) 		VMP
(n=356)
Median age (range) 71 (40-93) 71 (50-91)
Sex Percent  
Male 46% 47%
Female 54% 53%
Race
Caucasian 85% 85%
Black or African American 1% 1%
Asian 13% 13%
Other <1% <1%
Unknown <1% <0%
Not reported <1% <1%
ECOG performance status
0 22% 28%
1 52% 49%
2 26% 24%
ECOG=Eastern Cooperative Oncology Group.

Daratumumab (DARZALEX®) in combination with bortezomib, melphalan, and prednisone 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.2.2020. © National Comprehensive Cancer Network, Inc. 2020. Accessed January 4, 2020. 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.

EFFICACY – ALCYONE