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A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM) · Source last updated 2023-02-24

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

groups

1. description

   Mezagitamab 45 mg, subcutaneously (SC), once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.

   id

   FG000

   title

   Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg

2. description

   Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

   id

   FG001

   title

   Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg

3. description

   Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

   id

   FG002

   title

   Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg

4. description

   Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

   id

   FG003

   title

   Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg

5. description

   Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

   id

   FG004

   title

   Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg

6. description

   Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.

   id

   FG005

   title

   Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex

7. description

   Mezagitamab, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. TAK-079 dose for this phase was to be determined based on review of the available safety, efficacy, pharmacokinetic, and pharmacodynamic data obtained from the Phase 1 portion of the study. However, Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

   id

   FG006

   title

   Phase 2a: Mezagitamab

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         12

      4. group Id

         FG003

         num Subjects

         22

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         6

      7. group Id

         FG006

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         12

      4. group Id

         FG003

         num Subjects

         22

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         6

      7. group Id

         FG006

         num Subjects

         0

      type

      COMPLETED

   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

      7. group Id

         FG006

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with a diagnosis of relapsed or refractory (R/R) multiple myeloma (MM) were enrolled in Phase 1 to receive mezagitamab in a dose escalating manner and in combination with PomDex. Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

recruitment Details

Participants took part in the study at 7 investigative sites in the United States from 20 April 2018 to 28 January 2022.

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Preserved source evidence · Not medical advice