2017 ASCO Annual Meeting!
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Type: Oral Abstract Session
Time: Sunday June 4, 9:45 AM to 12:45 PM
Carfilzomib-lenalidomide-dexamethasone (KRd) vs carfilzomib-cyclophosphamide-dexamethasone (KCd) induction: Planned interim analysis of the randomized FORTE trial in newly diagnosed multiple myeloma (NDMM).
Hematologic Malignancies—Plasma Cell Dyscrasia
2017 ASCO Annual Meeting
J Clin Oncol 35, 2017 (suppl; abstr 8003)
Author(s): Francesca Maria Gay, Delia Rota Scalabrini, Angelo Belotti, Massimo Offidani, Maria Teresa Petrucci, Fabrizio Esma, Angelo D. Palmas, Tommaso Caravita, Mariella Grasso, Sara Aquino, Barbara Gamberi, Renato Zambello, Antonio Ledda, Vittorio Montefusco, Paola Omedè, Monica Galli, Michele Cavo, Antonio Palumbo, Pellegrino Musto, Mario Boccadoro; Myeloma Unit, Division of Hematology, University of Torino, Torino, Italy; Italian Multiple Myeloma Network, Gimema, Italy; Division of Hematology and Bone Marrow Transplantation, National Tumor Institute, University of Milan, Milan, Italy
Background: Phase I/II studies showed the safety and efficacy of KRd and KCd in NDMM pts (Jakubowiak Blood 2012, Bringhen Blood 2014). Methods: NDMM pts ≤65 yrs were randomized (1:1:1; stratification ISS and age) to: 4 28-day KCd cycles (carfilzomib:20/36 mg/m2 IV d 1,2,8,9,15,16; cyclophosphamide 300 mg/m2 d 1,8,15; dexamethasone:20 mg d 1,2,8,9,15,16) followed by MEL200-ASCT and consolidation with 4 KCd cycles; or 4 28-day KRd cycles (carfilzomib and dexamethasone as above; lenalidomide:25 mg d 1-21) followed by MEL200-ASCT and 4 KRd cycles; or 12 KRd cycles. After the 4th induction cycle, all pts received Cyclophosphamide 2 g/m2, followed by PBSC collection. We report results of the first planned safety interim analysis on induction and mobilization and preliminary efficacy data. We pooled the 2 KRd groups since treatment was the same until mobilization. Data cut-off was October 30, 2016. Results: 281 pts were evaluated (KCd, n=94; KRd, n=187). The most frequent grade 3-4 AEs plus SAEs in both arms were hematological (mainly neutropenia) and infections (mainly pneumonia/fever); increased AST/ALT/GGT (mainly reversible) and dermatological (rash) AEs were higher in KRd; cardiac AEs were 2% (atrial fibrillation[1%]/ischemic heart disease[1%]) in KRd vs 1% (atrial fibrillation) in KCd. In KCd, 1 pt died of infection (not treatment-related) vs 3 in the KRd (2 cardiac arrest [1 not treatment-related],1 infection not treatment-related). In the KCd vs KRd arms, 99% vs 95% (P=0.44) of pts mobilized stem cells (median number of PBSC collected:9 vs 6x10^6CD34/Kg with KCd vs KRd); 10% vs 24% (P=0.01) required Plerixafor. Rate of ≥VGPR was 61% with KCd vs 74% with KRd (P=0.05). Conclusions: Safety profile was acceptable; more pts required plerixafor in KRd. Rate of VGPR was higher with KRd. Updated data on more patients will be presented at the meeting. Clinicaltrials.gov NCT02203643.
|Grade 3-4 AEs/SAEs||KCd||KRd|
|Acute Kidney Injury||0%||2%|
*p value <0.05