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

• Sponsor: Pfizer (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04798586
• Collaborator: (none)
• Enrollment: 4
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 25.9
• Patients Per Site: 2
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsed or Refractory Multiple Myeloma	Drug: Elranatamab (PF-06863135)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 22, 2021
• Actual Primary Completion Date: May 27, 2022
• Anticipated Study Completion Date: May 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elranatamab (PF-06863135) BCMA-CD3 bispecific antibody	Drug: Elranatamab (PF-06863135); BCMA-CD3 bispecific antibody

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Dose Limiting Toxicity (DLT) [up to 28 days]

   Number of participants with DLTs, which are typically Grade 3 or higher adverse events

Secondary Outcome Measures

1. frequency of treatment-emergent adverse events [approximately 2 years]

   type and severity (including severity per NCI CTCAE v5)

2. frequency of laboratory abnormalities [approximately 2 years]

   complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)

3. Maximum plasma concentration (Cmax) of PF-06863135 [4 weeks]

   Peak concentration of elranatamab (PF-06863135)

4. immunogenicity of PF-06863135 [approximately every 1 to 3 cycles (approximately 2 years)]

   Incidence and titers of anti-drug antibodies and neutralizing antibodies against elranatamab (PF-06863135)

5. overall response rate [approximately every 3 weeks for approximately 2 years]

   overall response rate (IMWG response criteria)

6. time to response [approximately every 3 weeks (approximately 2 years)]

   time to response (IMWG response criteria)

7. duration of response [approximately every 3 weeks (approximately 2 years)]

   duration of response (IMWG response criteria)

8. progression free survival [approximately every 3 weeks (approximately 2 years)]

   progression free survival (IMWG response criteria)

9. overall survival [approximately every 3 months (approximately 2 years)]

   overall survival

10. minimal residual disease [approximately 2 years]

    minimal residual disease (IMWG MRD criteria)

11. systemic soluble immune factors [approximately 9 months]

    pre and post dose quantification of soluble cytokines in serum

12. area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135 [4 weeks]

    AUC of elranatamab (PF-06863135)

13. Trough serum concentrations of PF-06863135 [approximately 2 years]

    Trough concentrations of (PF-06863135)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nagoya City University Hospital	Nagoya	Aichi	Japan	467-8602
2	Japanese Red Cross Medical Center	Shibuya-ku	Tokyo	Japan	150-8935

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04798586
• Other Study ID Numbers: C1071002
• First Posted: Mar 15, 2021
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jun 22, 2022