Study on a Slow and Gentle Treatment Approach for Very Frail Patients with Multiple Myeloma Using Isatuximab, Dexamethasone, and Lenalidomide

Sponsor: University of Utah

Sponsor score: 0

ClinicalTrials ID:NCT06517017

Provider View

This clinical trial is exploring a gentle and gradual treatment method for very frail patients with multiple myeloma, using a combination of Isatuximab, Dexamethasone, and Lenalidomide. The aim is to see if this approach can help patients stick to their treatment plan and improve their quality of life.

Patient Parameters

Program Overview

The study focuses on very frail patients with multiple myeloma, a type of blood cancer, who often struggle with standard treatments. Researchers are testing a slow and gentle treatment method that starts with Isatuximab and Dexamethasone, and gradually introduces Lenalidomide from the third cycle. The goal is to see if this approach helps patients continue their treatment and feel better overall.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Diagnosed with multiple myeloma or Plasma Cell Leukemia, and have had no more than one cycle of previous treatment.
  • Women who can have children must have a negative pregnancy test or be post-menopausal or surgically sterilized.
  • Must agree to use birth control and participate in the Lenalidomide safety program.
  • Men must use a latex condom during sex, even if they have had a vasectomy.
  • Must have recovered from any side effects of previous treatments to a mild level or less, unless they are stable and not significant.
  • Must be able to understand the study and agree to participate by signing a consent form.
  • Must have a frailty score of 3 or higher according to the International Myeloma Working Group (IMWG).

Exclusion Criteria

  • Currently taking other experimental treatments.
  • Any condition that makes it hard to understand the study, give consent, or safely participate, such as infections, blockages, or difficulty swallowing pills.
  • Severe allergies to any of the study drugs or their ingredients that cannot be managed with pre-treatment medications.
  • Taking medications that are not allowed in the study.

Locations

FACILITYZIPCITYSTATE
Huntsman Cancer Institute at the University of Utah84112Salt Lake CityUtah

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