Elranatamab + Lenalidomide + Dexamethasone for Multiple Myeloma

Overseen By Carl O Landgren, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Miami

Must be taking: Lenalidomide, Dexamethasone

Must not be taking: Antiretrovirals, Live vaccines

Disqualifiers: CNS involvement, Major surgery, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

104 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the effects that Elranatamab in combination with Lenalidomide and Dexamethasone has on participants that have been newly diagnosed with Multiple Myeloma.

Research Team

Carl O Landgren, MD

Principal Investigator

Professor of Medicine

Eligibility Criteria

This trial is for individuals newly diagnosed with Multiple Myeloma, a type of blood cancer. Participants should meet specific health criteria set by the study team but these are not detailed here.

Inclusion Criteria

I am not pregnant and agree to regular pregnancy tests during the study.

My condition has caused damage to my organs or other serious health issues.

I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

My cancer has spread to my brain or spinal cord.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to the experimental agents used in study

I have a condition like HIV, hepatitis, COPD, asthma, COVID-19, or a heart problem.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Elranatamab in combination with Lenalidomide and Dexamethasone (ERd) for up to 24 cycles

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Elranatamab

Trial Overview The trial tests how effective Elranatamab combined with Lenalidomide and Dexamethasone is in treating new cases of Multiple Myeloma compared to standard treatments.

Participant Groups

Group I: Elranatamab in combination with lenalidomide and dexamethasone (ERd) Experimental Treatment 3 Interventions

Participants in this group will receive standard of care (SOC) therapy with ERd combination treatment. Total participation duration is up to 2.5 years.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Pfizer

Industry 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