NCT04798586 · REGISTRY CONDITION SEARCH

MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2024-09-27

The purpose of this study is to confirm the safety and tolerability of elranatamab (PF-06863135) in Japanese participants with relapsed or refractory MM.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose Limiting Toxicities (DLTs)

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outcome · POSTED

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs

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outcome · POSTED

Number of Participants With Grade 3 or 4, Grade 5 TEAEs and Treatment Related TEAEs Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Except for CRS and ICANS Graded According to ASTCT Grading Criteria 2019

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outcome · POSTED

Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Hematology Parameters by NCI CTCAE v 5.0

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outcome · POSTED

Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Chemistry Parameters by NCI CTCAE v 5.0

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outcome · POSTED

Maximum Observed Serum Concentration (Cmax) of Elranatamab

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outcome · POSTED

Time to Maximum Concentration (Tmax) of Elranatamab

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outcome · POSTED

Area Under the Concentration-time Profile From Time Zero to the Time Tau (AUCtau) of Elranatamab

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outcome · POSTED

Pre-dose Trough Serum Concentrations After Multiple Doses of Elranatamab

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outcome · POSTED

Number of Participants With Anti-drug Antibodies (ADA) of Elranatamab

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outcome · POSTED

Titers of ADA

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outcome · POSTED

Number of Participants With Neutralizing Antibodies (NAb)

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outcome · POSTED

Objective Response Rate (ORR): Percentage of Participants With Objective Response

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outcome · POSTED

Time to Response (TTR)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Minimal Residual Disease (MRD) Negativity Rate

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Diagnosis of multiple myeloma (IMWG criteria) * Measurable disease, as defined by at least 1 of the following 1. Serum myeloma (M) protein ≥0.5 g/dL (5 g/L) 2. Urine M protein ≥200 mg/24 h 3. Serum free light chain (FLC) \>100 mg/L (10 mg/dL) with abnormal kappa:lambda ratio * Participants must have progressed on or been intolerant of at least 3 prior therapies including proteasome inhibitor, IMID drug and anti-CD38 antibody, either in combination or as a single agent * ECOG PS 0, 1 or 2. PS 3 is permitted if PS is due solely to bone pain * Adequate bone marrow, hematological, kidney and liver function * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 * Not pregnant and willing to use contraception Exclusion Criteria: * POEMS syndrome * Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * History of active autoimmune disorders * Any form of primary immunodeficiency * History of severe immune-mediated adverse event with prior immunomodulatory treatment * Stem cell transplant within 12 weeks prior to enrollment * Active graft versus host disease other than Grade 1 skin involvement, or that requiring immunosuppressive treatment * Requirement for systemic immune suppressive medication * Active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, known HIV or AIDS related illness and SARS-CoV2 * Previous administration with an investigational drug within 4 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer) * Known or suspected hypersensitivity to component of elranatamab (PF-06863135), murine and bovine products * Live attenuated vaccine within 4 weeks
healthy Volunteers: false
minimum Age: 20 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
BCMA-CD3 bispecific antibody
intervention Names
Drug: Elranatamab (PF-06863135)
label
Elranatamab (PF-06863135)
type
EXPERIMENTAL

interventions

arm Group Labels
Elranatamab (PF-06863135)
description
BCMA-CD3 bispecific antibody
name
Elranatamab (PF-06863135)
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 4
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
DLT was defined as any of the following: Treatment Emergent Adverse Events (AEs) occurring in Cycle 0 and Cycle 1 (total 4 weeks): Grade (G) 4 neutropenia lasting greater than (\>)7 days; febrile neutropenia (absolute neutrophil count \[ANC\] less than (\<)1,000 per millimeter cube (/mm\^3) with single temperature \>38.3 degree Celsius (deg C), or sustained temperature of greater than or equal to (\>=) 38deg C for \>1 hour \[h\]); G\>=3 neutropenia with infection; G4 thrombocytopenia (unless the baseline count was \>=25,000/mm\^3 and \<50,000/mm\^3, in which case G4 thrombocytopenia was to be accompanied by \>=G2 bleeding), Platelet count \<10,000/mm\^3 was considered a DLT irrespective of other factors; G3 thrombocytopenia with \>=G2 bleeding; G4 AEs; G3 AE \>=5 days despite optimal supportive care (except AEs attributed to cytokine release syndrome \[CRS\]); G3 CRS (except CRS that have not been maximally treated or improved to \<=G1 within 48h); confirmed drug induced liver injury.
measure
Number of Participants With Dose Limiting Toxicities (DLTs)
time Frame
Up to 4 weeks

secondary Outcomes

description
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. An SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. A TEAE was defined as an AE that first occurred from the first dose of the study intervention until 90 days after the last dose or the day before starting a new anticancer therapy, whichever occurred first. Treatment related AEs and SAEs were defined as AEs and SAEs which was related to the treatment.
measure
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs
time Frame
From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment)
description
CTCAEv5.0 G3:severe/clinically significant;G4:life-threatening;G5:death.ASTCT CRS G3:temp\>=38degC,hypotension required vasopressor with/without vasopressin and/or hypoxia required high-flow nasal cannula,facemask,nonrebreather mask or venturi mask;G4:temp\>=38degC,hypotension required multiple vasopressors(excluding vasopressin)and/or hypoxia required positive pressure;G5:death.ICANS G3:ICE score0-2,awakens only to tactile stimulus,clinical seizure focal/generalized resolves rapidly or nonconvulsive seizures on electroencephalography resolve with intervention,focal/local edema on neuroimaging;G4:ICEscore 0(unarousable unable to perform ICE),unarousable or requires vigorous/repetitive tactile stimuli to arouse,stupor/coma,life-threatening prolonged seizure(\>5 min),repetitive clinical/electrical seizure without return to baseline,deep focal motor weakness,diffuse cerebral edema on neuroimaging,decerebrate/decorticate posturing,cranial nerve VI palsy,papilledema,Cushing's triad;G5:death.
measure
Number of Participants With Grade 3 or 4, Grade 5 TEAEs and Treatment Related TEAEs Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Except for CRS and ICANS Graded According to ASTCT Grading Criteria 2019
time Frame
From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment)
description
Hematology parameters that were assessed included: Anemia, Lymphocyte count decreased, Neutrophil count decreased, Platelet count decreased, White blood cell decreased. Abnormalities were graded based on National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 - Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
measure
Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Hematology Parameters by NCI CTCAE v 5.0
time Frame
From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment)
description
Chemistry parameters that were assessed included: Alanine aminotransferase increased, Alkaline phosphatase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Creatinine increased, Hypercalcemia, Hyperkalemia, Hypermagnesemia, Hypernatremia, Hypoalbuminemia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hypomagnesemia, Hyponatremia. Abnormalities were graded based on CTCAE version 5.0- Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
measure
Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Chemistry Parameters by NCI CTCAE v 5.0
time Frame
From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment)
measure
Maximum Observed Serum Concentration (Cmax) of Elranatamab
time Frame
Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]
measure
Time to Maximum Concentration (Tmax) of Elranatamab
time Frame
Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]
description
Area under the concentration-time profile from time zero to the time tau where the dosing interval (tau = 1 week). AUCtau was determined using the linear/log trapezoidal method.
measure
Area Under the Concentration-time Profile From Time Zero to the Time Tau (AUCtau) of Elranatamab
time Frame
Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]
measure
Pre-dose Trough Serum Concentrations After Multiple Doses of Elranatamab
time Frame
At pre-dose on Day 1 of Cycle 0, 3, 4, 5, 6, 7, 8, 12, 16; at pre-dose on Days 1, 8, 15 of Cycle 1 and 2
description
'A participant was considered ADA positive if baseline titer was missing or negative and participant had \>=1 post-treatment positive titer, or positive titer at baseline and had a \>=4-fold increase in titer from baseline in \>=1 post-treatment sample.
measure
Number of Participants With Anti-drug Antibodies (ADA) of Elranatamab
time Frame
From the date of first dose up to maximum of 65.1 weeks of treatment
description
Titers of ADA at specified timepoints were reported in this outcome measure.
measure
Titers of ADA
time Frame
Cycle1 Day1, Cycle1 Day15, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1, Cycle6 Day1, Cycle8 Day1, Cycle12 Day1, Cycle16 Day1, End of treatment (maximum of 65.1 weeks of treatment)
description
A participant was considered NAb positive if baseline titer was missing or negative and participant had \>=1 post-treatment positive titer, or positive titer at baseline and had a \>=4-fold increase in titer from baseline in \>=1 post-treatment sample.
measure
Number of Participants With Neutralizing Antibodies (NAb)
time Frame
From the date of first dose up to maximum of 65.1 weeks of treatment
description
ORR:% of participants with best overall response; confirmed stringent complete response(sCR),CR, very good partial response(VGPR) or PR per International Myeloma Working Group criteria.sCR: CR\& normal serum free light chain(sFLC)ratio \&absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum \&urine, disappearance of soft tissue plasmacytoma \&\<5% plasma cells in BMA, if disease measured by sFLC only,preceding criteria plus normal sFLC ratio.VGPR:Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum\&urine M-protein level \<100mg/24h.PR:\>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. If serum \& urine M-protein unmeasurable,VGPR \& PR: \>=90% \&\>=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline,\>=90% \& \>=50% reduction in soft tissue plasmacytomas' size.
measure
Objective Response Rate (ORR): Percentage of Participants With Objective Response
time Frame
From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (maximum of 65.1 weeks of treatment)

Full study description

brief Summary: The purpose of this study is to confirm the safety and tolerability of elranatamab (PF-06863135) in Japanese participants with relapsed or refractory MM.

Source references

references

citation
Hibma JE, Irby D, Liu A, Elmeliegy M, King LE, Gifondorwa D, Jiang S, Poels KE, Soltantabar P, Lon HK, Shtylla B, Wang D, Williams JH, Nicholas T. Elranatamab Population Pharmacokinetics and Exposure-Response for Cytokine Release Syndrome in Patients with Relapsed or Refractory Multiple Myeloma. Clin Pharmacokinet. 2026 Aug;65(8):1173-1192. doi: 10.1007/s40262-026-01663-z. Epub 2026 Jun 13.
pmid
42287565
type
DERIVED
citation
Lon HK, Hibma J, Jiang S, Sullivan S, Vandendries E, Skoura A, Wang D, Elmeliegy M. Population Exposure-Response Efficacy Analysis of Elranatamab (PF-06863135) in Patients with Multiple Myeloma. Target Oncol. 2025 Sep;20(5):803-819. doi: 10.1007/s11523-025-01168-y. Epub 2025 Aug 18.
pmid
40826257
type
DERIVED
citation
Elmeliegy M, Viqueira A, Vandendries E, Hickman A, Conte U, Irby D, Hibma J, Lon HK, Piscitelli J, Soltantabar P, Skoura A, Jiang S, Wang D. Dose Optimization of Elranatamab to Mitigate the Risk of Cytokine Release Syndrome in Patients with Multiple Myeloma. Target Oncol. 2025 Mar;20(2):349-359. doi: 10.1007/s11523-025-01134-8. Epub 2025 Feb 25.
pmid
40000533
type
DERIVED
citation
Iida S, Ito S, Yokoyama H, Ishida T, Nagai Y, Handa H, Ito S, Kamei Y, Nakamura M, Suzuki K. Elranatamab in Japanese patients with relapsed/refractory multiple myeloma: results from MagnetisMM-2 and MagnetisMM-3. Jpn J Clin Oncol. 2024 Sep 4;54(9):991-1000. doi: 10.1093/jjco/hyae068.
pmid
38794892
type
DERIVED