Participant flow

Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia · Source last updated 2021-04-23

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

groups

1. description

   Combination of everolimus \& rituximab for 6 cycles Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)

   id

   FG000

   title

   Phase I Stage A Level 1

2. description

   Combination of everolimus \& rituximab for 6 cycles Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)

   id

   FG001

   title

   Phase I Stage A Level 2

3. description

   Combination of everolimus \& rituximab with bortezomib for 6 cycles Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)

   id

   FG002

   title

   Phase I Stage B Level 1

4. description

   Combination of everolimus \& rituximab with bortezomib for 6 cycles Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)

   id

   FG003

   title

   Phase I Stage B Level 2

5. description

   Combination of everolimus \& rituximab with bortezomib for 6 cycles Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)

   id

   FG004

   title

   Phase I Dose Expansion

6. description

   Combination of everolimus \& rituximab with bortezomib for 6 cycles Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)

   id

   FG005

   title

   Phase II

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         5

      6. group Id

         FG005

         num Subjects

         12

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         8

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Symptomatic Deterioration

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         1

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         2

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         3

      5. comment

         Per protocol, a 10 patient expansion cohort is used to confirm the MTD determined in Stage B .

         group Id

         FG004

         num Subjects

         10

      6. group Id

         FG005

         num Subjects

         23

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         3

      5. comment

         The Phase I dose expansion cohort was not evaluated for cycle 1 dose-limiting toxicity.

         group Id

         FG004

         num Subjects

         0

      6. comment

         The Phase II cohort was not evaluated for cycle 1 dose-limiting toxicity.

         group Id

         FG005

         num Subjects

         0

      type

      Evaluable for Phase I Dose-Limiting Toxicity

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      comment

      Since treatment was not of fixed duration, all participants were considered as 'Not Completed' and reason off-treatment is provided.

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         10

      6. group Id

         FG005

         num Subjects

         23

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Participants were enrolled from April 2010 to July 2013.

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Preserved source evidence · Not medical advice