Clinical trial NCT04798586: MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma
Official title: A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETIC OF PF 06863135, A B CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsed or Refractory Multiple Myeloma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities (DLTs)
timeFrame: Up to 4 weeks
Secondary outcomes:
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
timeFrame: 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: 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
timeFrame: 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: 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
timeFrame: 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: 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
timeFrame: 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
timeFrame: 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
timeFrame: 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: Area Under the Concentration-time Profile From Time Zero to the Time Tau (AUCtau) of Elranatamab
timeFrame: 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
timeFrame: 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
measure: Number of Participants With Anti-drug Antibodies (ADA) of Elranatamab
timeFrame: From the date of first dose up to maximum of 65.1 weeks of treatment
measure: Titers of ADA
timeFrame: 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)
measure: Number of Participants With Neutralizing Antibodies (NAb)
timeFrame: From the date of first dose up to maximum of 65.1 weeks of treatment
measure: Objective Response Rate (ORR): Percentage of Participants With Objective Response
timeFrame: 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)
measure: Time to Response (TTR)
timeFrame: From date of first dose to the first documentation of objective response that is subsequently confirmed (maximum of 65.1 weeks of treatment)
measure: Duration of Response (DOR)
timeFrame: From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurs first, or censoring date (maximum of 65.1 weeks of treatment)
measure: Progression Free Survival (PFS)
timeFrame: From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurs first, or censoring date (maximum of 65.1 weeks of treatment)
measure: Overall Survival (OS)
timeFrame: From the date of first dose until death due to any cause or censoring date (maximum of 65.1 weeks of treatment)
measure: Minimal Residual Disease (MRD) Negativity Rate
timeFrame: 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)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: