Iberdomide Maintenance Therapy in Patients With Multiple Myeloma

NCT05177536 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 0852-21-FB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Lenalidomide maintenance therapy following autologous stem cell transplant (ASCT) is standard of care for patients with multiple myeloma. However, nearly all patients will experience disease relapse and lenalidomide's toxicity profile leads to treatment discontinuation in 30% of patients after one year. Iberdomide is a novel potent cereblon E3 ligase modulator with a favorable side effect profile. Investigators hypothesize that iberdomide maintenance therapy may result in at least 80% of subjects completing one year of maintenance. This study will determine the feasibility, safety and efficacy of iberdomide maintenance therapy post-autologous stem cell transplant (ASCT). Around day 100 after ASCT, patients will be assessed to determine study eligibility. Enrolled participants will take iberdomide pills by mouth on days 1-21 of each 28 day cycle. Physical exams, well-being status and blood and/or urine sampling will be conducted and evaluated before each cycle. Treatment will continue until disease progression or toxicity. Follow-up visits with similar testing will occur every 12 weeks until disease relapse or progression or another treatment for the disease is begun.The results from this study will inform the feasibility of pursuing a study comparing iberdomide to lenalidomide maintenance post-ASCT.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Able to Complete a Minimum of One Year of Ttherapy

  The number of eligible participants who remain on study receiving iberdomide for at least one year without disease progression among all eligible study participants who began protocol treatment will be determined.

  1 year

Secondary Outcomes (6)

• Median Progression-free Survival

  5 years

• Minimal Residual Disease-negativity Rate at Day 100

  100 Days

• Minimal Residual Disease-negativity Rate at One Year

  1 year

• Minimal Residual Disease-negativity Rate at Two Years

  2 years

• Sustained Minimal Residual Disease-negativity Rate

  1 year

Study Arms (1)

Iberdomide

EXPERIMENTAL

Iberdomide will be dosed at 1.0 mg orally daily on days 1-21 of a 28-day cycle

Drug: Iberdomide

Interventions

Iberdomide DRUG

Iberdomide is a novel potent cereblon E3 ligase modulator

Also known as: cereblon E3 ligase modulator

Iberdomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old at consent, ≥19 years old in Nebraska (age of consent)
• Willing and able to provide informed consent to and abide by the protocol
• Documented diagnosis of active measurable Multiple Myeloma (MM):
• M-protein (serum and/or urine protein electrophoresis (SPEP or UPEP)): SPEP ≥ 0.5 g/dL or UPEP ≥ 200 mg/24 hours and/or
• Light chain MM without measurable disease in the serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa-lambda free light chain ratio
• Prior MM therapy
• Initiation of induction therapy within 12 months of enrollment
• No prior progression after initial therapy (participants whose induction therapy changed because of suboptimal response or intolerance remain eligible, provided they do not meet criteria for progression as per the 2016 International Myeloma Working Group (IMWG) Response Criteria and no more than two regimens allowed, excluding dexamethasone alone
• No prior allogeneic hematopoietic stem cell transplant or solid organ transplant
• Autologous Stem Cell Transplant (ASCT) with high dose melphalan (140-200 mg/m2) and in a documented continued partial response or better, per IMWG criteria at 80-110 day post-ASCT
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• All participants must agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of study treatment
• All male and female participants must follow all requirements defined in the Pregnancy Prevention Plan in the protocol
• Female participants of childbearing potential (FCBP), achieved menarche at some point; has not undergone a hysterectomy or bilateral oophorectomy and not naturally postmenopausal for at least 24 consecutive months, i.e, has had menses at any time in the preceding 24 consecutive months; (amenorrhea following cancer therapy does not rule out childbearing potential) must:
• Have two negative serum or urine pregnancy tests as verified by investigators prior to starting study treatment

You may not qualify if:

• Participation in another clinical study with an investigational product within 28 days prior to enrollment
• Female who is pregnant, nursing or breastfeeding, or who intends to become pregnant during study participation
• Any significant medical condition or psychiatric illness that would prevent participation in the study as determined by the treating physician
• Multiple Myeloma (MM) disease progression, as defined by 2016 International Myeloma Working Group (IMWG) Response Criteria following Autologous Stem Cell Transplant (ASCT) prior to enrollment
• Non-secretory MM
• Plasma cell leukemia or light chain amyloidosis
• Any of the following laboratory abnormalities within 14 days of enrollment:
• Absolute neutrophil count (ANC) \< 1,000/μL
• Platelet count \< 75,000/μL
• Corrected serum calcium \> 13.5 mg/dL (\> 3.4 mmol/L)
• Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST)or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) ≥ 2.0 x upper limit of normal (ULN)
• Serum total bilirubin and alkaline phosphatase \> 1.5 x ULN
• Serious renal impairment (\[CrCl\] \< 50 mL/min) or requiring dialysis
• Peripheral neuropathy ≥ Grade 2
• Gastrointestinal disease that may significantly alter absorption of iberdomide or inability to take medications by mouth

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (2)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

iberdomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sarah A Holstein, MD, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: June 14, 2022
• Primary Completion: January 2, 2026
• Study Completion (Estimated): January 1, 2031
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)