Multiple Myeloma Clinical Trial

A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment

Summary

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)

Measurable disease, as defined by at least 1 of the following:

Serum M-protein >0.5 g/dL by SPEP
Urinary M-protein excretion >200 mg/24 hours by UPEP
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 is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

76

Study ID:

NCT05014412

Recruitment Status:

Recruiting

Sponsor:

Pfizer

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 36 Locations for this study

See Locations Near You

Mayo Clinic Hospital
Phoenix Arizona, 85054, United States
Mayo Clinic
Scottsdale Arizona, 85259, United States
Poudre Valley Hospital
Fort Collins Colorado, 80524, United States
Cancer Care & Hematology - Fort Collins
Fort Collins Colorado, 80528, United States
UCHealth Cancer Care & Hematology - Greeley
Greeley Colorado, 80634, United States
UCHealth Cancer Care & Hematology - Loveland
Loveland Colorado, 80538, United States
UF Health Shands Cancer Hospital
Gainesville Florida, 32608, United States
UF Health Shands Hospital
Gainesville Florida, 32610, United States
Pikeville Medical Center, INC
Pikeville Kentucky, 41501, United States
Tulane Cancer Center
New Orleans Louisiana, 70112, United States
Tulane Medical Center
New Orleans Louisiana, 70112, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
MSK Bergen
Montvale New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
MSK Nassau
Uniondale New York, 11553, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland Ohio, 44195, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
St. David's South Austin Medical Center
Austin Texas, 78704, United States
Blood Cancer and Stem Cell Transplant Clinic
San Antonio Texas, 78229, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio Texas, 78229, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City Utah, 84112, United States
Nagoya City University Hospital
Nagoya Aichi, 467-8, Japan
Kobe City Medical Center General Hospital
Kobe-city Hyogo, 650-0, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
Japanese Red Cross Medical Center
Shibuya-ku Tokyo, 150-8, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto , 602-8, Japan
China Medical University Hospital
Taichung , 40447, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
Taipei Veterans General Hospital
Taipei City , 11217, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
University Hospital Southampton NHS Foundation Trust
Southampton Hampshire, SO16 , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton Surrey, SM2 5, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London , SE1 9, United Kingdom
King's College Hospital NHS Foundation Trust
London , SE5 9, United Kingdom
University College London Hospitals NHS Foundation Trust NIHR
London , W1T 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

76

Study ID:

NCT05014412

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.