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NCT05090566 · OUTCOME

SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation

MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma · Source last updated 2026-04-24

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 35 days)

What was measured

DLT- Hematological:Grade (G)4 neutropenia \>5 days; febrile neutropenia; G\>=3 neutropenia, infection; G4 thrombocytopenia; G3 thrombocytopenia and G\>=2 bleeding. Non-hematological: G\>=4 adverse events(AEs); G3 cytokine release syndrome(CRS) \[except CRS not been maximally treated or improved to G\<=1 in 48 hours\]; G3 AEs (except AEs attributed to CRS, G3 nausea, vomiting, diarrhea that improve to G2\<=72 hours after maximal medical management has been initiated, G3 fatigue \< 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G3-4 laboratory abnormalities(except not associated with clinical sequelae and improve to G=\<2 in 72 hours); G2 clinically important/persistent AEs(cause significant dose delay/reduction) may be DLT; G3 injection site reaction, allergic reaction, anaphylaxis. Common Terminology Criteria for Adverse Events(CTCAE) version 5.0: G1:mild AE, G2:moderate, G3:severe, G4:life-threatening consequences; urgent intervention indicated, G5:death related to AE.

Analysis population: DLT evaluable analysis set included all enrolled participants who received at least 1 dose of the study intervention in the Phase 1b part of the study and either experience DLT(s) or complete the DLT observation period without DLT. Participants without DLTs who received less than the minimum requirement of the planned doses of each investigational product (IP) were not evaluable for DLTs.

Groups in this outcome

SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1

Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 4 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.

SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2

Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 8 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 12 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.

SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3

Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.

SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A

Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.

SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A

Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 76 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.

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

Analysis denominator · Participants

GroupSource count
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 12
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 24
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 38
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A7
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 10Not reportedNot reportedNot reportedNot reported
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 20Not reportedNot reportedNot reportedNot reported
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 34Not reportedNot reportedNot reportedNot reported
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A0Not reportedNot reportedNot reportedNot reported
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      5
    units
    Participants
description
DLT- Hematological:Grade (G)4 neutropenia \>5 days; febrile neutropenia; G\>=3 neutropenia, infection; G4 thrombocytopenia; G3 thrombocytopenia and G\>=2 bleeding. Non-hematological: G\>=4 adverse events(AEs); G3 cytokine release syndrome(CRS) \[except CRS not been maximally treated or improved to G\<=1 in 48 hours\]; G3 AEs (except AEs attributed to CRS, G3 nausea, vomiting, diarrhea that improve to G2\<=72 hours after maximal medical management has been initiated, G3 fatigue \< 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G3-4 laboratory abnormalities(except not associated with clinical sequelae and improve to G=\<2 in 72 hours); G2 clinically important/persistent AEs(cause significant dose delay/reduction) may be DLT; G3 injection site reaction, allergic reaction, anaphylaxis. Common Terminology Criteria for Adverse Events(CTCAE) version 5.0: G1:mild AE, G2:moderate, G3:severe, G4:life-threatening consequences; urgent intervention indicated, G5:death related to AE.
groups
  1. description
    Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 4 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
    id
    OG000
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1
  2. description
    Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 8 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 12 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
    id
    OG001
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2
  3. description
    Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
    id
    OG002
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3
  4. description
    Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.
    id
    OG003
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A
  5. description
    Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 76 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.
    id
    OG004
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A
param Type
COUNT_OF_PARTICIPANTS
population Description
DLT evaluable analysis set included all enrolled participants who received at least 1 dose of the study intervention in the Phase 1b part of the study and either experience DLT(s) or complete the DLT observation period without DLT. Participants without DLTs who received less than the minimum requirement of the planned doses of each investigational product (IP) were not evaluable for DLTs.
reporting Status
POSTED
time Frame
From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 35 days)
title
SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice