- 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
Kd vs Vd study design
The largest head-to-head superiority study comparing two proteasome inhibitors1
Phase 3, randomized, open-label study (N = 929) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 lines of therapy2
Phase 3, head-to-head superiority trial between 2 proteasome inhibitors1,2
Inclusion criteria allowed for diverse patient types
Key inclusion criteria1,2
- Relapsed or refractory multiple myeloma
- 1 to 3 prior treatments
- ECOG PS 0-2
- Prior treatment with V or K was allowed if
- ≥ PR to prior treatment
- ≥ 6-month PI treatment-free interval
- Not discontinued due to toxicity
- LVEF ≥ 40%
- Creatinine clearance ≥ 15 mL/min
Key exclusion criteria1,2
- Grade 3 or 4 PN (or Grade 2 with pain) within 14 days prior to randomization
- Myocardial infarction within 4 months prior to randomization
- NYHA Class III or IV heart failure
- < PR to all prior regimens
The patients studied in the Kd vs Vd trial may resemble the patients in your practice
Select patient demographics and baseline characteristics1,2
Characteristic | Kd (n = 464) | Vd (n = 465) |
---|---|---|
Age | ||
Median, years (range) | 65 (35-89) | 65 (30-88) |
≥ 75 years, n (%) | 77 (17) | 66 (14) |
ECOG Performance Status, n (%) | ||
0 | 221 (48) | 232 (50) |
1 | 210 (45) | 203 (44) |
2 | 33 (7) | 30 (6) |
ISS stage, n (%) | ||
I | 219 (47) | 212 (46) |
II | 138 (30) | 153 (33) |
III | 107 (23) | 100 (22) |
Cytogenetic risk category by FISH, n (%) | ||
High | 97 (21) | 113 (24) |
Standard | 284 (61) | 291 (63) |
Unknown* | 83 (18) | 61 (13) |
Creatinine clearance, n (%) | ||
< 30 mL/min | 28 (6) | 28 (6) |
30 to < 50 mL/min | 57 (12) | 71 (15) |
50 to < 80 mL/min | 186 (40) | 177 (38) |
≥ 80 mL/min | 193 (42) | 189 (41) |
Baseline neuropathy, n (%) | ||
Grade 1 | 133 (29) | 159 (34) |
Grade 2 | 10 (2) | 10 (2) |
Prior regimens at baseline2
Prior regimens at baseline | Kd (n = 464) | Vd (n = 465) |
---|---|---|
Number of prior regimens, median (range) | 2 (1-3) | 2 (1-3)† |
Prior regimens, n (%) | ||
1 | 232 (50) | 231 (50) |
2 | 158 (34) | 144 (31) |
3 | 74 (16) | 88 (19) |
Prior therapies, n (%) | ||
Bortezomib | 250 (54) | 252 (54) |
Stem cell transplant | 266 (57) | 272 (59) |
Thalidomide | 212 (46) | 249 (54) |
Lenalidomide | 177 (38) | 178 (38) |
Bortezomib plus immunomodulatory agent | 159 (34) | 168 (36) |
Refractory to last prior therapy, n (%) | 184 (40) | 189 (41) |
Note: Refractory was defined as disease not achieving a minimal response or better, progressing during therapy, or progressing within 60 days after completion of therapy.2