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Trial record 1 of 1 for:    NCT03158688
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Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (CANDOR)

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ClinicalTrials.gov Identifier: NCT03158688
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):

May 9, 2017
May 18, 2017
January 5, 2018
June 13, 2017
September 1, 2019   (Final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: 28 months ]
Compare carfilzomib, dexamethasone, and daratumumab (KdD) to carfilzomib and dexamethasone (Kd) in terms of progression free survival (PFS) in patients with multiple myeloma who have relapsed after 1 to 3 prior therapies.
Same as current
Complete list of historical versions of study NCT03158688 on ClinicalTrials.gov Archive Site
  • Overall Response Rate (ORR) [ Time Frame: 28 Months ]
    Overall Response Rate (ORR; defined as the proportion of best overall response of stringent complete response [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]).
  • Rate of minimal residual disease negative-complete response [ Time Frame: 12 Months ]
    Rate of minimal residual disease negative-complete response (MRD[-]CR) in bone marrow aspirates at 12 months (± 4 weeks) as determined by Next-Generation sequencing (NGS).
  • Duration of response (DOR) [ Time Frame: 28 Months ]
  • Overall survival (OS) [ Time Frame: 28 Months ]
  • Time to next treatment [ Time Frame: 28 Months ]
  • time to progression (TTP) [ Time Frame: 28 Months ]
  • Time to response [ Time Frame: 28 Months ]
  • Persistence of MRD[-]CR [ Time Frame: 28 Months ]
  • Complete response rate (CRR) [ Time Frame: 28 Months ]
  • MRD[-] rate [ Time Frame: 12 Months ]
    MRD[-]CR rate, MRD[-]CR defined as achievement of CR by IRC per International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) and MRD[-] status as assessed by NGS (at a 10-5 level, pending analytical validation) at 12 months
  • Quality of life questionnaire - core 30 items [ Time Frame: 28 Months ]
    Quality of life questionnaire - core 30 items (QLQ-C30).
  • Quality of Life (QoL) measured by European Organization [ Time Frame: 28 Months ]
    Quality of Life (QoL) measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3 questionnaire.
  • Subject incidence of treatment-emergent adverse events [ Time Frame: 28 Months ]
  • Overall Response Rate (ORR) [ Time Frame: 28 Months ]
    Overall Response Rate (ORR; defined as the proportion of best overall response of stringent complete response [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]).
  • Rate of minimal residual disease negative-complete response [ Time Frame: 28 Months ]
    Rate of minimal residual disease negative-complete response (MRD[-]CR) in bone marrow aspirates at 12 months (± 4 weeks) as determined by Next-Generation sequencing (NGS).
  • Duration of response (DOR) [ Time Frame: 28 Months ]
  • Overall survival (OS) [ Time Frame: 28 Months ]
  • Time to next treatment [ Time Frame: 28 Months ]
  • time to progression (TTP) [ Time Frame: 28 Months ]
  • Time to response [ Time Frame: 28 Months ]
  • Persistence of MRD[-]CR [ Time Frame: 28 Months ]
  • Complete response rate (CRR) [ Time Frame: 28 Months ]
  • MRD[-] rate [ Time Frame: 28 Months ]
    MRD[-]CR rate, MRD[-]CR defined as achievement of CR by IRC per International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) and MRD[-] status as assessed by NGS (at a 10-5 level, pending analytical validation) at 12 months
  • Quality of life questionnaire - core 30 items [ Time Frame: 28 Months ]
    Quality of life questionnaire - core 30 items (QLQ-C30).
  • Quality of Life (QoL) measured by European Organization [ Time Frame: 28 Months ]
    Quality of Life (QoL) measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3 questionnaire.
  • Subject incidence of treatment-emergent adverse events [ Time Frame: 28 Months ]
Not Provided
Not Provided
 
Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma.
A Randomized, Open-label, Phase 3 Study Comparing Carfilzomib, Dexamethasone, and Daratumumab to Carfilzomib and Dexamethasone for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma CANDOR Study of Carfilzomib ANd Daratumumab fOr Relapsed Myeloma
Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone (Kd) in terms of progression free survival (PFS) in patients with multiple myeloma who have relapsed after 1 to 3 prior therapies.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Relapsed or Refractory Multiple Myeloma
  • Drug: Dexamethasone
    Dexamethasone 40 mg will be taken orally or by IV infusion weekly. The IV administration of dexamethasone must be given on carfilzomib and/or daratumumab IV infusion days. Dexamethasone IV will be given on successive days at a split dose of 20 mg each treatment day on weeks with carfilzomib and/or daratumumab infusions. All subjects regardless of age will be required to receive 20 mg of dexamethasone on days 1 and 2 of cycle 1 (as a preinfusion medication for daratumumab infusion) followed by 20 mg of methylprednisolone or equivalent on the third day.
  • Drug: Daratumumab
    Daratumumab will be administered as an IV infusion. On days 1 and 2 of cycle 1, daratumumab will be administered at a split-dose of 8 mg/kg in 500 mL normal saline. The dose of 16 mg/kg in 500 mL normal saline will be given once weekly as a single infusion for the remaining doses of the first 2 cycles (ie, days 8, 15, and 22 of cycle 1; and days 1, 8, 15, and 22 of cycle 2), then every 2 weeks for 4 cycles (cycles 3 to 6), and then every 4 weeks for the remaining cycles or until disease progression. The administration may be within ± 2 days for each scheduled dose.
  • Drug: Carfilzomib

    Carfilzomib will be administered as an intravenous (IV) infusion. On days when more than 1 investigational product is administered, the required order of administration is as follows: dexamethasone, pre-infusion medications for daratumumab, carfilzomib, daratumumab, and post infusion medications for daratumumab.

    Carfilzomib will be dosed twice weekly over 30 ± 5 minutes, on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The administration may be within ± 2 days for each scheduled dose. The dose will be 20 mg/m2 on cycle 1 days 1 and 2 and 56 mg/m2 beginning on cycle 1 day 8 and thereafter.

    Each subject's first dose of carfilzomib will be calculated based upon baseline body surface area (BSA). Dose should be capped based on a BSA of 2.2 m2.

  • Active Comparator: Arm 2 - Carfilzomib and Dexamethasone

    Carfilzomib will be dosed twice weekly as an intravenous (IV) infusion and Dexamethasone will be taken orally or by IV infusion weekly. The IV administration of dexamethasone must be given on carfilzomib IV infusion days. The required order of administrationon Arm 2 is as follows: dexamethasone then carfilzomib.

    For days when dexamethasone is given in the absence of carfilzomib IV infusion, it may be given orally (PO).

    Interventions:
    • Drug: Dexamethasone
    • Drug: Carfilzomib
  • Active Comparator: Arm 1 - Carfilzomib, Dexamethasone and Daratumumab
    Carfilzomib will be dosed twice weekly as an intravenous (IV) infusion. Daratumumab will be administered as an IV infusion - on days 1 and 2 of cycle 1 at 8 mg/kg dose each day; then at 16 mg/kg dose once weekly as a single infusion for the remaining doses of the first 2 cycles; then every 2 weeks for 4 cycles (cycles 3 to 6), and then every 4 weeks for the remaining cycles or until disease progression. Dexamethasone 40 mg will be taken orally or by IV infusion weekly. The IV administration of dexamethasone must be given on carfilzomib and/or daratumumab IV infusion days. On days when more than 1 investigational product is administered, the required order of administration is as follows: dexamethasone, pre-infusion medications for daratumumab, carfilzomib, daratumumab, and post-infusion medications for daratumumab.
    Interventions:
    • Drug: Dexamethasone
    • Drug: Daratumumab
    • Drug: Carfilzomib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
June 17, 2022
September 1, 2019   (Final data collection date for primary outcome measure)

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 detectable 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, see Appendix E for guidance)
  • Criteria 5 Prior therapy with carfilzomib is allowed as long as the patient had at least a 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 x 109/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 < 50% of predicted normal
  • Criteria 8 Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization
  • Other exclusion criteria may apply
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Czechia,   France,   Greece,   Hungary,   Japan,   Korea, Republic of,   Poland,   Romania,   Russian Federation,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
 
 
NCT03158688
20160275
2016-003554-33 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP