CANDOR Study
A randomized, open-label, active-controlled, multicentre, phase 3 study

Demonstrated safety profile in the phase 3 CANDOR study
  • Adverse Reactions
    Adverse Reactions in the Study Safety Population (reported in ≥20% of patients in the KdD arm)1
    KdD (n=308) Kd (n=153)
    All Grades ≥Grade 3 All Grades ≥Grade 3
    Most Common Adverse Reactions in the Blood and Lymphatic System [number of patients (%)]
    Thrombocytopenia* 115 (37.3) 76 (24.7) 46 (30.1) 25 (16.3)
    Anemia† 101 (32.8) 51 (16.6) 48 (31.4) 22 (14.4)
    Most Common Adverse Reactions in Other Organ Systems [number of patients (%)]
    Respiratory tract infection‡ 124 (40.3) 22 (7.1) 45 (29.4) 5 (3.3)
    Diarrhea 97 (31.5) 12 (3.9) 22 (14.4) 1 (0.7)
    Hypertension 94 (30.5) 54 (17.5) 42 (27.5) 20 (13.1)
    Fatigue 75 (24.4) 24 (7.8) 28 (18.3) 7 (4.6)
    Cough§ 63 (20.5) 0 (0.0) 32 (20.9) 0 (0.0)
    The median treatment duration with study drug was:1
    • 70 weeks for KdD
    • 40 weeks for Kd
  • Serious Adverse Reactions
    Most Common Serious Adverse Reactions in the Study Safety Population1¶
    Pneumonia Dyspnea
    Urinary tract infection Cardiac failure
    Influenza Acute kidney injury
    Sepsis Anemia
    Pyrexia Plasma cell myeloma
    Pulmonary embolism
    Serious adverse events were reported in:
    • 56% (n=172) of the patients in the KdD arm
    • 46% (n=70) of the patients in the Kd arm
  • Selected Other Adverse Reactions
    Selected Less Common Adverse Reactions (<5%) in the Study Safety Population1∆#
    KdD (n=308)
    Renal and Urinary Disorders
    Acute kidney injury 3.9%
    Renal impairment 1.3%
    Renal failure 1.0%
    Cardiac Disorders
    Cardiac failure 4.9%
    Tachycardia 4.2%
    Atrial fibrillation 2.9%
    Palpitations 2.9%
    Cardiac arrest 1.0%
    Myocardial infarction 1.0%
    Myocardial ischemia 0.6%
    Pericardial effusion 0.3%
STUDY DESIGN
BASELINE
CHARACTERISTICS
Learn about the CANDOR Study by reading the trial abstract.
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* Thrombocytopenia includes Platelet Count Decreased PT and Thrombocytopenia PT.

† Anemia includes Anemia PT, Hematocrit Decreased PT and Hemoglobin Decreased PT.

‡ Respiratory Tract Infection includes Respiratory Tract Infection PT, Lower Respiratory Tract Infection, Upper Respiratory Tract Infection PT and Viral Upper Respiratory Tract Infection.

§ Cough includes Productive Cough PT, and Cough PT.

¶ Occurred with ≥2% incidences in either treatment arm.

∆ Refer to the KYPROLIS Product Monograph for a complete list of adverse reactions.

# All adverse reactions <5% are based on the KdD twice weekly arm and were not categorized by grade in the KYPROLIS Product Monograph.

Kd, KYPROLIS + dexamethasone; KdD, KYPROLIS + dexamethasone + daratumumab; PT, preferred term.

Baseline characteristics were well-balanced between both groups1,13
Characteristics KdD (n=312) Kd (n=154)
Age
Median (years) 64 65
Range (years) 29–84 35–83
Distribution [number of patients (%)]
18–64 years 163 (52) 77 (50)
>65 years 149 (48) 77 (50)
ECOG Performance Status [number of patients (%)]
0 or 1 15 (5) 7 (5)
2 2 (1) 0 (0)
Cytogenic Risk at Study Entry [number of patients (%)]
High risk 48 (15) 26 (17)
Standard risk 104 (33) 52 (34)
Unknown 160 (51) 76 (49)
Creatinine Clearance Distribution [number of patients (%)]
≥15 to <30 mL/min 5 (2) 3 (2)
≥30 to <50 mL/min 33 (11) 24 (16)
≥50 to <80 mL/min 97 (31) 50 (33)
≥80 mL/min 176 (56) 77 (50)
Missing 1 (<1) 0 (0)
Previous therapies in patients participating in the CANDOR study
ITT Population [number of patients (%)]1,13
Previous Regimens* KdD (n=312) Kd (n=154)
1 regimen 144 (46) 70 (46)
2 regimens 99 (32) 46 (30)
3 regimens 69 (22) 37 (24)
Lenalidomide 123 (39) 74 (48)
Bortezomib 287 (92) 134 (87)
Carfilzomib 7 (2) 2 (1)
CD38 antibody therapy 1 (<1) 0 (0)
Stem cell transplant (ASCT) 195 (63) 75 (49)
Study eligibility:1
  • Patients with relapsed or refractory multiple myeloma were eligible
  • Patients must have received 1 to 3 prior lines of therapy

* Only one patient (0.2%) on the study (Kd arm) had received >3 prior lines of therapy.

ASCT, autologous stem cell transplant; ECOG, Eastern Cooperative Oncology Group; ITT, intent to treat; Kd, KYPROLIS® + dexamethasone; KdD, KYPROLIS + dexamethasone + daratumumab.

CANDOR was a randomized, open-label, active-controlled, multicentre, phase 3 study with the following study design1
Patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy (N=466) were randomized 2:1 to KdD twice weekly (n=312) which consisted of KYPROLIS® (carfilzomib; 20/56 mg/m2), dexamethasone (40 mg weekly) and daratumumab IV (8/16 mg/kg), or Kd twice weekly (n=154) consisting of KYPROLIS (carfilzomib; 20/56 mg/m2) and dexamethasone (40 mg weekly). The primary endpoint was progression-free survival (PFS).

All patients continued receiving treatment until disease progression or unacceptable toxicity.1

PFS was determined by an Independent Review Committee.1

Kd, KYPROLIS + dexamethasone; KdD, KYPROLIS + dexamethasone + daratumumab; PFS, progression-free survival.