RecruitingPhase 2NCT04776395

Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma

Iberdomide in Intermediate- and High-Risk Smoldering Myeloma (SMM) Patients: A Phase 2 Study With a Safety Run-in


Sponsor

Emory University

Enrollment

68 participants

Start Date

Jul 9, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies the effects of iberdomide when given alone or in combination with dexamethasone in treating intermediate or high-risk smoldering multiple myeloma patients. Immunotherapy with iberdomide may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Dexamethasone is a synthetic steroid (similar to steroid hormones produced naturally in the adrenal gland), and is used with other drugs in the treatment of some types of cancer. Giving iberdomide with dexamethasone my improve time to progression to symptomatic myeloma with improved tolerability.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called iberdomide (alone or with a low-dose steroid called dexamethasone) for people with smoldering multiple myeloma (SMM) — a pre-cancer blood condition that hasn't yet caused symptoms but is at intermediate or high risk of progressing to full myeloma. The goal is to see if early treatment can delay or prevent progression. **You may be eligible if...** - You have been diagnosed with intermediate- or high-risk smoldering multiple myeloma within the past 5 years - Your blood or bone marrow shows specific markers of higher risk (e.g., many plasma cells in the bone marrow, abnormal protein levels) - You are in reasonable physical condition (ECOG 0–2) - Your blood counts are adequate **You may NOT be eligible if...** - You already have active (symptomatic) multiple myeloma - You were diagnosed with SMM more than 5 years ago - You have had prior treatment for myeloma - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexamethasone

Given PO

DRUGIberdomide Hydrochloride

Given PO

OTHERQuality-of-Life Assessment

Ancillary studies


Locations(1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

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NCT04776395


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