- 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
Safety: Kd once weekly study
The International Myeloma Society recommends modifying treatment by considering a once-weekly regimen for appropriate RRMM patients to reduce the number of hospital/clinic visits during the COVID-19 pandemic.5
Learn MoreSafety experience
Overall safety was comparable across treatment arms1
Discontinuation due to adverse reactions1,2
Safety experience with Kd 70 mg/m2 once weekly vs Kd 27 mg/m2 twice weekly1,2
- Deaths due to adverse reactions within 30 days of the last study treatment occurred in 9% of patients in the Kd 70 mg/m2 once weekly arm compared with 8% of patients in the Kd 27 mg/m2 twice weekly arm1
- The most frequent fatal adverse reactions occurring in patients in the 2 arms included (n, %): sepsis (2, < 1% vs 2, < 1%), septic shock (2, < 1% vs 1, < 1%), and infection (2, < 1% vs 0, 0%)1
- Dose reductions due to adverse reactions were reported in 11% of patients in the Kd once weekly arm vs 5% in the Kd twice weekly arm2
Safety profile
Additional safety and clinical considerations2
- The once-weekly dose of Kd 70 mg/m2 did not reveal any new cardiovascular safety risks1
- The overall incidence of cardiac failure events was 3.8% in the Kd 70 mg/m2 once weekly arm versus 5.1% in the Kd 27 mg/m2 twice weekly arm1
- The frequency of Grade ≥ 3 cardiac failure events was observed in 3% of Kd 70 mg/m2 once weekly patients2
- No new cardiac safety signals were seen in the Kd 70 mg/m2 once-weekly arm1,2
Select adverse reactions of interest1,2
Kd 70 mg/m2 once weekly (n = 238), n (%) |
Kd 27 mg/m2 twice weekly* (n = 235), n (%) |
|||
---|---|---|---|---|
All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |
Peripheral neuropathy | 10 (4) | 0 (0) | 16 (7) | 1 (< 1) |
Acute renal failure | 17 (7) | 9 (4) | 16 (7) | 13 (6) |
Cardiac failure1,2 | 9 (3.8) | 7 (3) | 12 (5.1) | 10 (4) |
Ischemic heart disease | 4 (2) | 2 (1) | 3 (1) | 2 (1) |
Pulmonary hypertension | 4 (2) | 0 (0) | 3 (1) | 1 (< 1) |
Most common adverse reactions occurring in ≥ 10% of patients in either treatment arm1
Adverse reactions by body system | Kd 70 mg/m2 once weekly (n = 238), n (%) |
Kd 27 mg/m2 twice weekly* (n = 235), n (%) |
||
---|---|---|---|---|
Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
Blood and lymphatic system disorders | ||||
Anemia† | 64 (27) | 42 (18) | 76 (32) | 42 (18) |
Thrombocytopenia‡ | 53 (22) | 26 (11) | 41 (17) | 27 (12) |
Neutropenia§ | 30 (13) | 21 (9) | 27 (12) | 17 (7) |
Gastrointestinal disorders | ||||
Diarrhea | 44 (19) | 2 (1) | 47 (20) | 3 (1) |
Nausea | 34 (14) | 1 (< 1) | 26 (11) | 2 (1) |
General disorders and administration site conditions | ||||
Pyrexia | 55 (23) | 2 (1) | 38 (16) | 4 (2) |
Fatigue | 48 (20) | 11 (5) | 47 (20) | 5 (2) |
Asthenia | 24 (10) | 3 (1) | 25 (11) | 2 (1) |
Peripheral edema | 18 (8) | 0 (0) | 25 (11) | 2 (1) |
Infections and infestations | ||||
Respiratory tract infection** | 70 (29) | 7 (3) | 79 (34) | 7 (3) |
Pneumonia | 28 (12) | 24 (10) | 20 (9) | 16 (7) |
Bronchitis | 27 (11) | 2 (1) | 25 (11) | 5 (2) |
Musculoskeletal and connective tissue disorders | ||||
Back pain | 28 (12) | 2 (1) | 28 (12) | 4 (2) |
Nervous system disorders | ||||
Headache | 25 (11) | 1 (< 1) | 23 (10) | 1 (< 1) |
Psychiatric disorders | ||||
Insomnia | 35 (15) | 2 (1) | 47 (20) | 0 (0) |
Respiratory, thoracic, and mediastinal disorders | ||||
Cough†† | 37 (16) | 2 (1) | 31 (13) | 0 (0) |
Dyspnea‡‡ | 28 (12) | 1 (< 1) | 26 (11) | 2 (1) |
Vascular disorders | ||||
Hypertension§§ | 51 (21) | 13 (6) | 48 (20) | 12 (5) |
Median treatment duration
The median treatment duration was 38 weeks in the Kd 70 mg/m2 once weekly arm vs 29 weeks in the Kd 27 mg/m2 twice weekly arm1,*
Median treatment duration (Kd 70 mg/m2 once weekly vs Kd 27 mg/m2 twice weekly)1,3
Select frail-subgroup safety profile (Kd 70 mg/m2 once weekly vs Kd 27 mg/m2 twice weekly)4,*
SELECT GRADE ≥ 3 TEAEs OF INTEREST
Select grade ≥ 3 TEAEs of interest, n | Kd 70 once weekly (n = 79) |
Kd 27 twice weekly (n = 60) |
---|---|---|
Peripheral neuropathy | 0 | 0 |
Acute renal failure | 3 | 4 |
Cardiac failure | 3 | 5 |
Ischemic heart disease | 0 | 1 |
Pulmonary hypertension | 0 | 1 |