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OncoMatch/Clinical Trials/NCT04776395

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

Is NCT04776395 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Dexamethasone and Iberdomide Hydrochloride for smoldering plasma cell myeloma.

Phase 2RecruitingEmory UniversityNCT04776395Data as of May 2026

Treatment: Dexamethasone · Iberdomide HydrochlorideThis 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.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: treatment for plasma cell disorder

Prior or ongoing treatment for plasma cell disorder

Lab requirements

Blood counts

ANC >= 1500/uL; Hgb > 11 g/dL; Platelet count >= 100,000 cells/mm^3 and must be platelet and PRBC transfusion independent with no G-CSF to ensure eligibility within 8 weeks of screening

Kidney function

Estimated creatinine clearance >= 30 mL/min as defined by CKD-EPI or Cockcroft-Gault

Liver function

Total bilirubin < 2 mg/dL except in subjects with congenital bilirubinemia such as Gilbert syndrome, in which case direct bilirubin <= 2 times the institutional upper limit of normal is required; AST and ALT < 2.5 times the institutional upper limit of normal

Cardiac function

Left ventricular ejection fraction >= 40%

ANC >= 1500/uL; Hgb > 11 g/dL; Platelet count >= 100,000 cells/mm^3 and must be platelet and PRBC transfusion independent with no G-CSF to ensure eligibility within 8 weeks of screening; Estimated creatinine clearance >= 30 mL/min as defined by CKD-EPI or Cockcroft-Gault; Total bilirubin < 2 mg/dL except in subjects with congenital bilirubinemia such as Gilbert syndrome, in which case direct bilirubin <= 2 times the institutional upper limit of normal is required; AST and ALT < 2.5 times the institutional upper limit of normal; Left ventricular ejection fraction >= 40%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Emory University Hospital/Winship Cancer Institute · Atlanta, Georgia

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