Participant flow

Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. · Source last updated 2025-05-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.

   id

   FG000

   title

   Kd - Carfilzomib and Dexamethasone

2. description

   Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.

   id

   FG001

   title

   KdD - Carfilzomib, Dexamethasone and Daratumumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         28

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         37

      type

      Decision by sponsor

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         74

      2. group Id

         FG001

         num Subjects

         142

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         154

      2. group Id

         FG001

         num Subjects

         312

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         153

      2. group Id

         FG001

         num Subjects

         308

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         49

      2. group Id

         FG001

         num Subjects

         102

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         105

      2. group Id

         FG001

         num Subjects

         210

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were randomized in 1:2 ratio to arms KD vs KdD after being stratified by 1) International Staging System (ISS) stage (Stage 1-2 vs Stage 3) at screening, 2) prior proteasome inhibitor exposure (yes/no), 3) number of prior lines of therapy (1 vs ≥ 2), and 4) prior cluster differentiation antigen 38 (CD38) antibody therapy (yes/no).

recruitment Details

This study was conducted at 102 centers. 569 participants were screened and 466 were enrolled. Primary analysis (PA) data cutoff (DCO): 14-Jul-2019. Final analysis (FA) DCO: 15-Apr-2022.

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Preserved source evidence · Not medical advice