Study on the Effects of Elranatamab, Daratumumab, and Lenalidomide Compared to a Standard Treatment in Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Sponsor: Pfizer

Sponsor score: 60

ClinicalTrials ID:NCT05623020

This clinical trial is exploring whether a new combination of drugs, Elranatamab, Daratumumab, and Lenalidomide, is more effective than the standard treatment for patients with newly diagnosed multiple myeloma who cannot undergo a transplant.

Patient Parameters

Program Overview

The study aims to find out if a new combination of medications—Elranatamab, Daratumumab, and Lenalidomide—can provide better results than the current standard treatment for people with newly diagnosed multiple myeloma who are not candidates for a transplant. The study has two parts: the first part will test the safety and best dose of the new combination, while the second part will compare how well the new combination works against the standard treatment in controlling the disease and preventing its progression.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with multiple myeloma, a type of blood cancer.
  • Have measurable signs of the disease based on specific medical tests.
  • For Part 1: Have either relapsed or refractory multiple myeloma and have tried 1-2 previous treatments, or have newly diagnosed multiple myeloma and are not eligible for a transplant due to age (65 or older) or other health issues.
  • For Part 2: Have newly diagnosed multiple myeloma and are not eligible for a transplant due to age or other health conditions that make high-dose chemotherapy and stem cell transplant too risky.
  • Have a performance status score of 2 or less, indicating the ability to carry out daily activities with some limitations.
  • Not pregnant and willing to use effective birth control.
  • For those with relapsed/refractory multiple myeloma: Any side effects from previous treatments should be resolved to a mild level or baseline.

Exclusion Criteria

  • Have a condition called smoldering multiple myeloma or other similar blood disorders.
  • Have active, uncontrolled infections, including COVID-19, hepatitis B or C, or HIV/AIDS.
  • Have had another active cancer within the last 3 years, except for certain skin cancers or very early-stage cancers with low risk of returning.
  • For those with relapsed/refractory multiple myeloma: Have received certain previous treatments targeting BCMA or CD38 within the last 6 months, or had a stem cell transplant within the last 3 months.
  • For those with newly diagnosed multiple myeloma: Have received any systemic treatment for multiple myeloma except for a short course of steroids.
  • Have received a live vaccine within 4 weeks before starting the study treatment.
  • Are currently participating in another clinical trial or have taken an investigational drug or vaccine within 30 days before starting this study.

Locations

FACILITYZIPCITYSTATE
MSK Basking Ridge07920Basking RidgeNew Jersey
MSK Monmouth07748MiddletownNew Jersey
MSK Bergen07645MontvaleNew Jersey
MSK Commack11725CommackNew York
MSK Westchester10604HarrisonNew York
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).10021New YorkNew York
Memorial Sloan Kettering Cancer Center - Main Campus10065New YorkNew York
Memorial Sloan Kettering Cancer Center-Main Campus10065New YorkNew York
MSK Nassau11553UniondaleNew York
The University of Texas MD Anderson Cancer Center77030HoustonTexas

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