Purpose

The purpose of this study is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014) - Measurable disease, as defined by at least 1 of the following: 1. Serum M-protein >0.5 g/dL by SPEP 2. Urinary M-protein excretion >200 mg/24 hours by UPEP 3. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio - Refractory to at least one IMiD - Refractory to at least one PI - Refractory to at least one anti-CD38 antibody - Relapsed/refractory to last anti-myeloma regimen - ECOG performance status ≤1 - Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1 - Not pregnant and willing to use contraception

Exclusion Criteria

  • Smoldering multiple myeloma - Active Plasma cell leukemia - POEMS syndrome - Amyloidosis - Waldenström's macroglobulinemia - Known active CNS involvement or clinical signs of myelomatous meningeal involvement - Stem cell transplant within 12 weeks prior to enrollment or active GVHD - Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection - 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 or Stage 0/1 malignancy with minimal risk of recurrence per investigator. - Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy. - Live attenuated vaccine within 4 weeks of the first dose - Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1
Evaluation of step-up priming dosing
  • Drug: Elranatamab
    BCMA-CD3 bispecific antibody
Experimental
Part 2A
Dose determination
  • Drug: Elranatamab
    BCMA-CD3 bispecific antibody
Experimental
Part 2B
Dose expansion
  • Drug: Elranatamab
    BCMA-CD3 bispecific antibody
Experimental
Part 2C
To explore higher dose intensity
  • Drug: Elranatamab
    BCMA-CD3 bispecific antibody

Recruiting Locations

Tulane Medical Center
New Orleans, Louisiana 70112

Tulane Cancer Center
New Orleans, Louisiana 70112

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center, Please reference C1071009
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Detailed Description

The purpose of this study is to evaluate the safety (in particular the rate of Grade ≥ 2 CRS) of a step-up priming dose regimen of elranatamab in participants with relapsed/refractory multiple myeloma. In addition, this study will assess the safety of different dosing regimens of elranatamab and if it can provide a clinical benefit in those participants. Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.