Carfilzomib (KYPROLIS®) in combination with daratumumab (Darzalex®) and dexamethasone (DKd) is included under “preferred regimens” as a treatment option for previously treated multiple myeloma2
Carfilzomib (KYPROLIS®) in combination with daratumumab (Darzalex®) and dexamethasone (DKd) has a category 1 designation in the NCCN Guidelines® for Multiple Myeloma (Version 3.2021) for previously treated multiple myeloma.
Responses by category3
~4 out of 10 patients
with a CR achieved an even deeper response of MRD negativity3,†
|Response||Multiple myeloma response criteria|
|Minimal residual disease-negative complete response (MRD-negative CR)||CR as defined below, plus absence of clonal plasma cells by NGS on bone marrow aspirate. Presence of a clone is defined as < 2 identical sequencing reads obtained after DNA sequencing of bone marrow aspirates using the LymphoSIGHT platform (or validated equivalent method) with a minimum sensitivity of 1 in 105 nucleated cells or higher|
|Complete response (CR)||Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates|
|Very good partial response (VGPR)||Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 hours|
|Partial response (PR)||≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg/24 hours
If the serum and urine M-protein are unmeasurable, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria
If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, ≥ 50% reduction in plasma cells is required in place of the M-protein, provided baseline bone marrow plasma cell percentage was ≥ 30%. In addition to these criteria, if present at baseline, a ≥ 50% reduction in the size (SPD)* of soft tissue plasmacytomas is also required
Adapted by permission from Elsevier Limited: Lancet Oncol. 2016;17(8):e328-e346, ©2016.
*Plasmacytoma measurements should be taken from the CT portion of the PET/CT, MRI scans, or dedicated CT scans where applicable. For patients with only skin involvement, skin lesions should be measured with a ruler. Measurement of tumor size will be determined by the SPD.
NGS = next-generation sequencing; DNA = deoxyribonucleic acid; M-protein = monoclonal protein; FLC = free light chain; SPD = sum of the products of the maximal perpendicular diameters of measured lesions; CT = computed tomography; PET = positron emission tomography; MRI = magnetic resonance imaging.
Not an actual patient
These results represent prespecified subgroup analyses of the CANDOR study; however, these analyses were not study objectives and the study was therefore not powered or adjusted for multiplicity to assess efficacy in these subgroups.4
‡Standard-risk defined as a patient without cytogenetic abnormalities that are considered high risk.4
PI = proteasome inhibitor; Len = lenalidomide; ISS = International Staging System.
DKd vs Kd study design: Phase 3, randomized, open-label, multicenter trial that compared KYPROLIS® plus daratumumab and dexamethasone (DKd) to KYPROLIS® plus dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy. 466 patients were randomized 2:1 to receive DKd (n = 312) or Kd (n = 154) twice weekly for 28-day cycles until disease progression or unacceptable toxicity. The primary endpoint was PFS. Select secondary endpoints included ORR, MRD-negative CR rate at 12 months, OS, and safety.3,4
1. Dimopoulos M, Quach H, Mateos MV, et al. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone in relapsed or refractory multiple myeloma: updated efficacy and safety results of the Phase 3 CANDOR study. Poster presented at: 62nd ASH Annual Meeting & Exposition; December 5-8, 2020 [virtual conference]. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.3.2021. National Comprehensive Cancer Network, Inc 2020. All rights reserved. Accessed November 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. 3. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 4. Dimopoulos M, Quach H, Mateos MV, et al. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study. Lancet. 2020;396:186-197. 5. Dimopoulos M, Quach H, Mateos MV, et al. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study [supplementary appendix]. Lancet. 2020;396:186-197. 6. Kumar S, Paiva B, Anderson K, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016;17:e328-346.
Please see accompanying full Prescribing Information.