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NCT04776018 · OUTCOME

Phase 2: CBR Based on IMWG Criteria

A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM) · Source last updated 2024-10-02

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 24 months

What was measured

CBR: percentage of participants with response of at least (SD for \>=3 months or better sCR, iCR, mCR, CR, very good partial response \[VGPR\], PR, minimal response \[MR\] or SD) per investigator assessment by IMWG. sCR: CR plus normal FLC ratio, absence of clonal cells in BM. iCR: sCR plus absence of phenotypical aberrant plasma in BM with minimum of 1 million total BM cells. mCR: CR plus negative allele-specific oligonucleotide polymerase chain reaction. CR: Negative immunofixation on serum, urine, disappearance soft tissue plasmacytomas, \<5% plasma cells in BM. VGPR: Serum, urine M-protein detectable by immunofixation but not on electrophoresis or \>90% reduction in serum M-protein+urine M-protein level \<100mg/24h. PR: \>50% reduction of serum M-protein and in 24h urinary M-protein by \>90% or to \<200mg/24h. MR:\>=25% but \<=49% reduction in serum M-protein, reduction in 24h urine M-protein by 50 to 89%. SD: No CR, VGPR, PR or PD.

Analysis population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.

Groups in this outcome

Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody

Participants were planned to receive TAK-981 recommended phase 2 dose (RP2D), infusion, intravenously, in combination with an anti-CD38 antibody (mezagitamab or daratumumab and hyaluronidase-fihj), injection, subcutaneously, for up to 24 cycles or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
CBR: percentage of participants with response of at least (SD for \>=3 months or better sCR, iCR, mCR, CR, very good partial response \[VGPR\], PR, minimal response \[MR\] or SD) per investigator assessment by IMWG. sCR: CR plus normal FLC ratio, absence of clonal cells in BM. iCR: sCR plus absence of phenotypical aberrant plasma in BM with minimum of 1 million total BM cells. mCR: CR plus negative allele-specific oligonucleotide polymerase chain reaction. CR: Negative immunofixation on serum, urine, disappearance soft tissue plasmacytomas, \<5% plasma cells in BM. VGPR: Serum, urine M-protein detectable by immunofixation but not on electrophoresis or \>90% reduction in serum M-protein+urine M-protein level \<100mg/24h. PR: \>50% reduction of serum M-protein and in 24h urinary M-protein by \>90% or to \<200mg/24h. MR:\>=25% but \<=49% reduction in serum M-protein, reduction in 24h urine M-protein by 50 to 89%. SD: No CR, VGPR, PR or PD.
groups
  1. description
    Participants were planned to receive TAK-981 recommended phase 2 dose (RP2D), infusion, intravenously, in combination with an anti-CD38 antibody (mezagitamab or daratumumab and hyaluronidase-fihj), injection, subcutaneously, for up to 24 cycles or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
    id
    OG000
    title
    Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody
population Description
The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.
reporting Status
POSTED
time Frame
Up to 24 months
title
Phase 2: CBR Based on IMWG Criteria
type
SECONDARY

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Preserved source evidence · Not medical advice