Study of Iberdomide in People With Multiple Myeloma Who Have Had an Autologous Hematopoietic Stem Cell Transplant (AHCT)

Running, not enrolling · Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to see if iberdomide is a safe and effective maintenance therapy option for people with Multiple Myeloma (MM) who have had an Autologous Hematopoietic Stem Cell Transplant (AHCT) and have already had lenalidomide as maintenance therapy. Patients will receive iberdomide treatment beyond 12 months if they continue to derive benefit from the treatment and will continue until progression of disease or unacceptable toxicity. Follow-up will be as per standard of care for a patient on maintenance therapy, and patients will not require additional research samples.

Key facts

Study ID

NCT05354557

Run by

Memorial Sloan Kettering Cancer Center

People needed

16

Starts

2022-04-26

Expected to finish

2027-04-26

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All Patients
• Histologic confirmation of multiple myeloma by the enrolling institution. Cohort specific eligibility below.
• Age 18-75
• Karnofsky performance greater than or equal to 70.
• Recovered to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding Grade 2 neuropathy.
• Laboratory criteria
• Absolute neutrophil count (ANC) greater than or equal to 1,000/mm3 without filgrastim use in the prior 14 days.
• Platelet count greater than 75,000/mm3 (without platelet transfusion in the previous 7 days or thrombopoietin mimetics in the previous 28 days)
• Hemoglobin greater than 8 g/dL (without red blood cell transfusion in the previous 7 days)
• Creatinine Clearance (CrCl) greater than or equal to 30 mL/min, measured or estimated by Cockcroft-Gault equation.
• Corrected serum calcium less than or equal to 13.5 mg/dL
• Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than or equal to 2.5 x upper limit of normal (ULN)
• Serum total bilirubin less than or equal to 2 x ULN. Patients who have been diagnosed with Gilbert's disease are permitted to exceed the defined bilirubin value of 2 x ULN
• International ratio (INR) or partial thromboplastin time (PTT) less than 1.5 x ULN unless on therapeutic anticoagulation
• Females of childbearing potential (defined below) have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL
• Cohort 1:
• Received a single prior autoHCT with melphalan ≥ 140mg/m2 and a ≥ 2x106 CD34+ cells/kg (actual body weight) less than or equal to 15 months from initiation of systemic anti-myeloma therapy
• Have been on lenalidomide maintenance at a dose of ≥ 5 mg every other day for at least 6 months.
• Have achieved a VGPR or less to treatment by International Myeloma Working Group Criteria
• Be within 15 months of their autoHCT
• Cohort 2:
• Have received 2 to 3 prior lines of systemic anti-myeloma therapy +/- prior autoHCT.
• Have had lenalidomide maintenance therapy after a line of treatment prior to the salvage autoHCT.
• Have undergone salvage autoHCT consolidation with a high dose melphalan based conditioning regimen within the prior 2-6 months
• Pregnancy

You may not qualify if…

• Prior allogeneic hematopoietic stem cell transplant
• Disease progression after most recent autoHCT prior to enrollment
• Known active central nervous system (CNS) involvement with MM
• Prior organ transplant requiring systemic immunosuppressive therapy
• History of a thromboembolic event while on full anticoagulation during prior therapy with an immunomodulatory agent (IMiD)
• Unwilling to take DVT prophylaxis while on iberdomide maintenance
• History of greater than or equal to Grade 2 hemorrhage within 30 days of enrollment
• History of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis
• Ongoing treatment with chronic immunosuppressants (eg, cyclosporine or systemic steroids at any dose). Physiologic replacement, intermittent topical, inhaled or intranasal corticosteroids are allowed.
• Seropositive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B (defined as positive hepatitis B surface antigen (HepBSAg) or Hepatitis B core antibody (HepBcore Ab)) or C (Hep C Ab), or acute hepatitis A. If any history of exposure to hepatitis B or C, then PCR should be negative.
• Prior malignancies except resected basal cell carcinoma or treated carcinoma in situ.
• Cancer treated with curative intent less than 5 years prior to enrollment will not be allowed unless approved by the MSK PI. Cancer treated with curative intent greater than 5 years prior to enrollment is allowed.
• Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide
• Uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
• Serious medical of psychiatric illness likely to interfere with participation on this clinical study
• Unwilling or unable to provide informed consent
• Unable or unwilling to return to the transplant center for treatment and follow up

Where it is running

• Memorial Sloan Kettering Basking Ridge (Consent and Followup) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Consent and Follow-Up only) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Consent and Follow up) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Suffolk-Commack (Consent and Follow up) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Consent and Follow Up) — Harrison, New York, United States
• Weill Cornell Medical College (Data Collection Only) — New York, New York, United States
• Memorial Sloan Kettering Cancer Center (All protocol activities) — New York, New York, United States
• Memorial Sloan Kettering Nassau (Consent and Followup) — Rockville Centre, New York, United States

Full record on ClinicalTrials.gov

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