Elranatamab +/- Dexamethasone for Multiple Myeloma

(MagnetisMM-9 Trial)

Recruiting at 57 trial locations

Overseen By Pfizer CT.gov Call Center, Please reference C1071009

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 25 cycles (approximately 2 years)

86 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study (Part 1 and Part 2) 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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for adults with multiple myeloma that has returned or didn't respond to treatment. They must have measurable disease, not be pregnant, and agree to use contraception. Excluded are those with certain other cancers or conditions like active infections, recent stem cell transplant, previous anti-BCMA therapy, or known hypersensitivity to the study drugs.

Inclusion Criteria

Any side effects from my previous treatments have mostly gone away.

My last treatment for myeloma did not work.

Not pregnant and willing to use contraception

Exclusion Criteria

I have been diagnosed with amyloidosis.

I do not have any active infections like HBV, HCV, HIV, or uncontrolled bacterial, fungal, or viral infections.

I have been diagnosed with POEMS syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elranatamab as an injection under the skin at the study clinic. Initial step-up doses followed by weekly doses.

25 cycles (approximately 2 years)

Weekly visits initially, decreasing over time

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days post last dose

Long-term follow-up

Participants are monitored for long-term outcomes and survival

Up to 790 days

Treatment Details

Interventions

• Dexamethasone
• Elranatamab

Trial Overview The trial tests Elranatamab alone or combined with Dexamethasone in patients with relapsed/refractory multiple myeloma. It starts with low doses that increase over time (step-up dosing) and looks at safety and effectiveness of different doses and dose intervals over a minimum two-year participation.

Participant Groups

Group I: Part 2C Experimental Treatment 1 Intervention

To explore higher dose intensity

Group II: Part 2B Experimental Treatment 1 Intervention

Dose expansion

Group III: Part 2A Experimental Treatment 1 Intervention

Dose determination

Group IV: Part 1 Experimental Treatment 1 Intervention

Evaluation of step-up priming dosing

Elranatamab is already approved in United States, European Union for the following indications:

Approved in United States as Elrexfio for:

• Relapsed or refractory multiple myeloma

Approved in European Union as Elrexfio for:

• Relapsed or refractory multiple myeloma

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University