- KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. ... Read More
DKd vs Kd study results
DKd significantly reduced the risk of disease progression or death by 37% vs Kd1
With a median follow-up of nearly 17 months, the majority of patients on DKd had not progressed, so median PFS has not yet been reached1,2
DKd: National Comprehensive Cancer Network® (NCCN®) preferred NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)3:
Carfilzomib (KYPROLIS®) in combination with daratumumab (Darzalex®) and dexamethasone (DKd) is included under “preferred regimens” as a treatment option for previously treated multiple myeloma3
Carfilzomib (KYPROLIS®) in combination with daratumumab (Darzalex®) and dexamethasone (DKd) has a category 1 designation in the NCCN Guidelines® for Multiple Myeloma (Version 2.2021) for previously treated multiple myeloma.
DKd more than DOUBLED the chance of achieving a complete response vs Kd1
DKd delivered higher ORR, ≥VGPR, CR, and MRD-negative CR than Kd, beginning at first relapse1
- ORR: Patients in the DKd arm achieved an ORR of 84% vs 75% for the Kd arm (P = 0.0040, one-sided)1,*
Responses by category1
~4 out of 10 patients
with a CR achieved an even deeper response of MRD negativity1,†
- 12% of patients achieved MRD-negative CR at 12 months with DKd vs 1.3% with Kd (P < 0.0001, one-sided)1,†
- MRD tests detect residual tumor cells in the bone marrow at 100x-10,000x lower concentration than conventional methods of assessing CR4,5,‡
IMWG uniform reponse criteria5
|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.
Meet Diane, a 65-year-old active female
Hypothetical case study of a high-risk* patient with multiple myeloma at first relapse
Chance for a powerful, deep, and durable response with DKd
- Recently retired and moved with her husband to be closer to their children
- Enjoys long walks and playing with her grandchildren
- Diagnosed with multiple myeloma after presenting with fatigue and bone pain
- High-risk cytogenetics with LDH greater than the upper limit of normal (275 IU/L)
- Transplant eligible
- ECOG PS 0
Not an actual patient
Exploratory analysis: PFS was consistent across clinically important subgroups2
PFS in predefined subgroups, including prior lenalidomide-exposed, lenalidomide-refractory, and prior PI-exposed2
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.2
†Standard-risk defined as a patient without cytogenetic abnormalities that are considered high risk.2
PI = proteasome inhibitor; Len = lenalidomide; ISS = International Staging System.