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Attend this session at the
2019 ASCO Annual Meeting!


Session: Hematologic Malignancies—Plasma Cell Dyscrasia

Type: Oral Abstract Session

Time: Sunday June 2, 9:45 AM to 12:45 PM

Location: E451

Efficacy of carfilzomib lenalidomide dexamethasone (KRd) with or without transplantation in newly diagnosed myeloma according to risk status: Results from the FORTE trial.

Sub-category:
Multiple Myeloma

Category:
Hematologic Malignancies—Plasma Cell Dyscrasia

Meeting:
2019 ASCO Annual Meeting

Abstract No:
8002

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 8002)

Author(s): Francesca Gay, Chiara Cerrato, Maria Teresa Petrucci, Renato Zambello, Barbara Gamberi, Stelvio Ballanti, Paola Omedè, Salvatore Palmieri, Rossella Troia, Stefano Spada, Alessandro Gozzetti, Tommaso Caravita, Antonio Spadano, Antonio Palumbo, Vittorio Montefusco, Pellegrino Musto, Michele Cavo, Mario Boccadoro; GIMEMA, European Myeloma Network, Italy; Myeloma Unit, Division of Hematology, University of Torino - Currently Takeda Pharmaceuticals Co., Torino, Zurich, Italy

Abstract Disclosures

Abstract:

Background: High and comparable rates of MRD negativity were seen in NDMM pts after 4 28-day induction cycles with KRd followed by ASCT and 4 KRd consolidation (KRd_ASCT_KRd) and after 12 KRd cycles (KRd12), showing the superiority of both regimens over KCd induction-ASCT-KCd consolidation (KCd-ASCT-KCd) (Gay F ASH 2018). Here we evaluated the benefit of KRd_ASCT_KRd vs KRd12 in specific subgroups of pts. Methods: 474 NDMM pts ≤65 years were randomized to KRd_ASCT_KRd or KRd12 or KCd_ASCT_KCd. We compared rate of ≥VGPR, ≥CR, sCR, MRD negativity (centralized, second generation flow cytometry, sensitivity 10-5) after consolidation with KRd_ASCT_KRd vs KRd12 in patients with R-ISS 1 and R-ISS 2/3. Since high-risk pts may sometimes respond rapidly, but then relapse early, we also analyzed the rate of early relapse (<18 months from randomization). We performed a multivariate logistic regression analysis to evaluate factors predictive of early relapse. Results: Median follow-up was 25 months. Rates of ≥VGPR, ≥CR, sCR, MRD negativity were comparable between KRd_ASCT_KRd and KRd12 overall, in pts with R-ISS Stage 1 and with R-ISS Stage 2/3 (Table). A significantly lower number of pts experienced early relapse with KRd_ASCT_KRd vs KRd12 (12 pts [8%] vs 26 pts [17%]; P=0.015). This difference was mainly related to a significantly lower rate of early relapse in R-ISS Stage 2/3 pts receiving KRd_ASCT_KRd vs KRd12 (11 pts [12%] vs 22 pts [23%]; P=0.05); no difference was seen in R-ISS 1 (0 vs 2 pts). In multivariate regression analysis, KRd_ASCT_KRd vs KRd12 reduced the risk of early progression (OR 0.42; P=0.021); R-ISS Stage 2 (OR 3.6; P=0.001) and R-ISS Stage 3 (OR 4.85; P=0.003) increased the risk compared with R-ISS 1. Conclusions: KRd-ASCT-KRd and KRd12 were equally effective in inducing high-quality responses, with about 50% of high-risk pts achieving MRD negativity. In high-risk pts ASCT reduced the risk of early relapse. Clinical trial information: NCT02203643

KRd_ASCT_KRd
N=158
KRd12
N=157
R-ISS 1
R-ISS 2/3
KRd_ASCT_KRd
N=48
KRd12
N=39
KRd_ASCT_KRd
N=92
KRd12
N=94
sCR44%43%46%49%39%38%
≥CR60%61%60%64%56%57%
≥VGPR89%87%92%79%86%86%
MRD negative58%54%69%62%51%47%

 
Other Abstracts in this Sub-Category:

 

1. Updated risk stratification model for smoldering multiple myeloma (SMM) incorporating the revised IMWG diagnostic criteria.

Meeting: 2019 ASCO Annual Meeting Abstract No: 8000 First Author: Jesus San Miguel
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

2. E3A06: Randomized phase III trial of lenalidomide versus observation alone in patients with asymptomatic high-risk smoldering multiple myeloma.

Meeting: 2019 ASCO Annual Meeting Abstract No: 8001 First Author: Sagar Lonial
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

3. Phase 3 randomized study of daratumumab (DARA) + bortezomib/thalidomide/dexamethasone (D-VTd) vs VTd in transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part 1 results.

Meeting: 2019 ASCO Annual Meeting Abstract No: 8003 First Author: Philippe Moreau
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

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