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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04776395
Phase
PHASE2
Status
Recruiting
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Conditions

  • Smoldering Plasma Cell Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Given PO
  • Iberdomide Hydrochloride — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jul 9, 2021
Status verified
May 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2029

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (iberdomide hydrochloride, dexamethasone)
    Patients receive iberdomide hydrochloride PO QD on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive iberdomide hydrochloride PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm B (iberdomide hydrochloride)
    Patients receive iberdomide hydrochloride PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall response rate [ Time Frame: Up to 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Bryan Burton
[email protected]
404-778-1780
Nisha S. Joseph, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Emory University Hospital/Winship Cancer Institute· Atlanta, GA

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