Study on Adjusting Linvoseltamab Dosage for Treating Relapsed or Resistant Multiple Myeloma

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07181941

Provider View

This clinical trial is exploring whether reducing the dose of linvoseltamab, based on patient response, can safely treat multiple myeloma that has returned or is resistant to treatment. Linvoseltamab is a special antibody that helps the immune system target and kill cancer cells.

Patient Parameters

Program Overview

The purpose of this study is to test if lowering the dose of linvoseltamab, a drug used to treat multiple myeloma, can still effectively manage the disease while reducing side effects. This study focuses on patients whose multiple myeloma has come back after treatment, does not respond to treatment, or is resistant to three types of drugs. Linvoseltamab works by helping the immune system recognize and attack cancer cells. The study will help determine the best dosing schedule for this medication.

Description

In this study, patients will receive linvoseltamab through an IV once a week for the first 14 weeks, and then every two weeks if the cancer does not progress or cause severe side effects. Patients will be checked for how well the treatment is working starting at week 3 and then every 4 weeks. If patients show a very good response after at least 14 weeks, they will be placed into one of three groups to receive lower doses of the drug at different intervals: every 4 weeks, every 8 weeks, or every 12 weeks. Throughout the study, patients will have regular blood tests and may have scans to monitor their condition. After finishing the treatment, patients will be followed up for 3 months to check on their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must understand and agree to sign a consent form.
  • Must have a confirmed diagnosis of active multiple myeloma.
  • Must have measurable myeloma according to specific medical criteria.
  • Must have myeloma that is resistant to three types of treatments or has progressed after at least three prior treatments.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Must have a creatinine clearance of at least 30 mL/min.
  • Must have resolved any side effects from previous BCMA-targeted treatments to a mild level.
  • Must be willing to comply with study visits and procedures.

Exclusion Criteria

  • Cannot have certain other types of blood cancers or conditions.
  • Cannot have brain lesions or cancer in the brain lining.
  • Cannot have a history of certain neurological conditions or recent seizures.
  • Cannot be on high doses of steroids or have received live vaccines recently.
  • Cannot have had CAR T therapy or gene therapy products before.
  • Cannot have had recent serious infections or uncontrolled infections like HIV, hepatitis B, or C.
  • Cannot be allergic to linvoseltamab.
  • Women who are pregnant or could become pregnant must not participate unless they meet specific criteria.
  • Cannot be taking other experimental drugs.
  • Must agree to use effective birth control during and after the study.
  • Cannot have uncontrolled illnesses or other cancers within the last 5 years, except for certain skin cancers.

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