Phase 3
Completed N=466
Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma.
Source: ClinicalTrials.gov NCT03158688 ↗Enrolled (actual)
466
Serious AEs
63.1%
Results posted
Sep 2020
Primary outcomePrimary: Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only) — 68; 110; 86; 202 Participants — p=0.0014
◆ Published Evidence
Highly cited
419citations · ~70 / year
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.
Summary
Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone (Kd) in terms of progression free survival (PFS) in participants with multiple myeloma who have relapsed after 1 to 3 prior therapies.
Linked Publications (5)
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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.
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Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): updated outcomes from a randomised, multicentre, open-label, phase 3 study.
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Final analysis of carfilzomib, dexamethasone, and daratumumab vs carfilzomib and dexamethasone in the CANDOR study.
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Efficacy and safety of weekly carfilzomib (70 mg/m<sup>2</sup>), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies.
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Health-Related Quality of Life in Patients With Relapsed/Refractory Multiple Myeloma Treated With Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone: An Analysis of Patient-Reported Outcomes From the Phase 3 CANDOR Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only) |
68; 110; 86; 202 | 0.0014 sig |
| SECONDARY Overall Response (OR) as Assessed by the Independent Review Committee (PA DCO Only) |
74.7; 84.3 | 0.0040 sig |
| SECONDARY Minimal Residual Disease Negative Complete Response Rate (MRD[-]CR) at 12 Months as Assessed by the Independent Review Committee |
1.9; 12.8 | — |
| SECONDARY Overall Survival |
43.6; 50.8 | 0.0417 sig |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
147; 306; 113; 253; 70; 173 | — |
| SECONDARY Kaplan-Meier Estimate for Duration of Response (DOR) (PA DCO Only) |
16.6; NA | — |
| SECONDARY Kaplan-Meier Estimate for Time to Next Treatment (TTNT) |
17.3; NA; 17.8; 37.4 | — |
| SECONDARY Kaplan-Meier Estimates for Time to Progression (TTP) as Assessed by the Independent Review Committee (PA DCO Only) |
17.5; NA | — |
| SECONDARY Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) |
90.0; 95.3; 79.4; 86.4; 62.7; 77.5 | — |
| SECONDARY Time to Overall Response as Assessed by the Independent Review Committee (PA DCO Only) |
1.5; 1.4 | — |
| SECONDARY Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More |
0.0; 0.0; 0.0; 5.8 | — |
| SECONDARY Percentage of Participants With a Complete Response (CR) as Assessed by the Independent Review Committee (PA DCO Only) |
10.4; 28.5 | — |
| SECONDARY Percentage of Participants Who Achieved Minimal Residual Disease Negative (MRD[-]) Status as Assessed by Next Generation Sequencing at 12 Months |
5.2; 18.3 | — |
| SECONDARY Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose |
66.19; 61.79; 64.35; 61.00; 66.13; 63.10 | 0.9480 |
Eligibility Criteria
Inclusion Criteria
- Criteria 1 Relapsed or progressive multiple myeloma after last treatment
- Criteria 2 Males or females ≥ 18 years of age
- Criteria 3 Measurable disease with at least 1 of the following assessed within 21 days prior to randomization:
- IgG multiple myeloma: serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL,
- IgA, IgD, IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL,
- urine M-protein ≥ 200 mg/24 hours,
- in subjects without measurable serum or urine M- protein, serum free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio
- Criteria 4 Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy
- Criteria 5 Prior therapy with carfilzomib is allowed as long as the patient had at least a partial response (PR) to most recent therapy with carfilzomib, was not removed due to toxicity, did not relapse within 60 days from discontinuation of carfilzomib, and will have at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not proteasome inhibitors or CD38 antibodies during this 6-month carfilzomib treatment free interval)
- Criteria 6 Prior therapy with anti-CD38 antibodies is allowed as long as the patient had at least a PR to most recent therapy with CD38 antibody, was not removed due to toxicity, did not relapse within 60 days from intensive treatment (at least every other week) of CD38 antibody therapy, and will have at least a 6 month CD38 antibody treatment-free interval from last dose received until first study treatment
- Other inclusion criteria may apply
Exclusion Criteria
- Criteria 1 Waldenström macroglobulinemia
- Criteria 2 Multiple myeloma of IgM subtype
- Criteria 3 POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Criteria 4 Plasma cell leukemia (> 2.0 * 10^9/L circulating plasma cells by standard differential)
- Criteria 5 Myelodysplastic syndrome
- Criteria 6 Known moderate or severe persistent asthma within the past 2 years
- Criteria 7 Known chronic obstructive pulmonary disease (COPD) with a FEV1 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization
- Other exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03158688) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.