Participant flow

Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma · Source last updated 2019-07-17

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

groups

1. description

   Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.

   id

   FG000

   title

   Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)

2. description

   Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.

   id

   FG001

   title

   Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)

3. description

   Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.

   id

   FG002

   title

   Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         40

      type

      Progressive Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         17

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         6

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Study Terminated by Sponsor

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         6

      type

      Reason not Specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         36

      2. group Id

         FG001

         num Subjects

         34

      3. group Id

         FG002

         num Subjects

         78

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         8

      comment

      Completed=Completed Study Treatment

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         28

      3. group Id

         FG002

         num Subjects

         70

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with NDMM were enrolled in 1 of 2 arms to receive 4.0 mg ixazomib in combination with 300 or 400 mg cyclophosphamide and 40 mg dexamethasone (CCd); participants with RRMM were enrolled in 1 arm to receive ixazomib 4.0 mg CCd. All arms included a safety lead-in cohort for pharmacokinetics (PK) analysis.

recruitment Details

Participants took part in the study at 23 investigative sites in Australia, Greece, Poland, Sweden and the United States from 05 March 2014 to 29 June 2018.

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Preserved source evidence · Not medical advice