Study on Iberdomide Alone or with Dexamethasone for Treating Intermediate- or High-Risk Smoldering Multiple Myeloma

Sponsor: Emory University

Sponsor score: 40

ClinicalTrials ID:NCT04776395

Provider View

This clinical trial is exploring the effects of iberdomide, alone or combined with dexamethasone, in patients with intermediate or high-risk smoldering multiple myeloma. The study aims to see if this treatment can delay the progression to active myeloma while being well-tolerated by patients.

Patient Parameters

Program Overview

This phase II study is testing whether iberdomide, an immunotherapy drug, can help control smoldering multiple myeloma by itself or when combined with dexamethasone, a steroid. The goal is to see if this combination can slow down the progression to active myeloma and improve patient outcomes. Iberdomide may help the immune system fight cancer cells, while dexamethasone is used to enhance the treatment's effectiveness.

Description

The main goal of this study is to find out how well iberdomide, alone or with dexamethasone, works in treating intermediate- and high-risk smoldering multiple myeloma. Researchers will look at how many patients respond to the treatment and how long they can go without the disease getting worse. They will also monitor the safety of the treatment and any side effects.

Patients will be randomly assigned to one of two groups:

  • Group A: Patients will take iberdomide daily for 21 days and dexamethasone on specific days over a 28-day cycle. This cycle will repeat for four times unless the disease progresses or side effects become unacceptable. Afterward, patients will continue with iberdomide alone.

  • Group B: Patients will take iberdomide daily for 21 days in a 28-day cycle, repeating as long as the treatment is effective and tolerable.

After finishing the treatment, patients will have follow-up visits to monitor their health and the treatment's long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with intermediate- or high-risk smoldering multiple myeloma within the last 5 years.
  • Meet specific medical criteria, such as a certain percentage of plasma cells in the bone marrow or abnormal protein levels in the blood.
  • Men and women of all races and ethnicities can participate.
  • Must be in good general health with a performance status score of 0 to 2.
  • Have adequate blood cell counts and organ function based on specific tests.
  • Women of childbearing potential must have negative pregnancy tests and agree to use effective birth control during the study and for a period afterward.
  • Men must agree to use contraception during the study and for 3 months after.
  • Willing to sign an informed consent form and comply with study requirements.

Exclusion Criteria

  • Have multiple myeloma that requires treatment.
  • Have other specific blood disorders or conditions like MGUS or POEMS syndrome.
  • Currently using certain medications or treatments that could interfere with the study.
  • Have active hepatitis B or C infections.
  • Have HIV with certain conditions.
  • Have uncontrolled illnesses or conditions that could affect participation.
  • Pregnant or breastfeeding women cannot participate due to potential risks to the baby.
  • Have used immunosuppressive medications recently, with some exceptions for low-dose or specific types of steroids.

Locations

FACILITYZIPCITYSTATE
Emory University Hospital/Winship Cancer Institute30322AtlantaGeorgia

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