Multiple MyelomaPhase 2NCT05177536
Iberdomide Maintenance Therapy in Patients With Multiple Myeloma
A Phase 2 study testing Iberdomide in people with Multiple Myeloma, run by University of Nebraska at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Iberdomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jun 2022to Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment, even if practicing true abstinence from heterosexual contact
- Commit to either true abstinence from heterosexual contact (reviewed on a monthly basis and source documented) or agree to use, and to comply with use of two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting investigational product, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of iberdomide
- Male participants must:
- Male participants must practice complete abstinence, acceptable when this aligns with the preferred and usual lifestyle of participant [periodic abstinence (e.g. calendar, ovulation, symptothermal or post-ovulation methods) and withdrawal are not acceptable methods] or agree to use a condom during sexual contact with a pregnant female or a FCBP while taking iberdomide, during dose interruptions and for at least 90 days following the last dose of iberdomide, even if he has undergone a successful vasectomy
- Must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 90 days following last dose of study treatment
Who cannot join
- 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
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- 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
- Prior history of malignancies, other than MM, unless free of the disease for ≥ 5 years prior to enrollment, excluding:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histological findings of prostate cancer such, e.g., T1a or T1b using Tumor/Node/Metastasis (TNM) classification of malignant tumors or prostate cancer that is curative
- History of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide
- Received any of the following within 14 days prior to enrollment:
- Plasmapheresis
- Major surgery (as defined by investigators
- Radiation therapy other than local therapy for MM associated bone lesions
- Use of any systemic myeloma drug therapy
- Any one of the following:
- Clinically significant abnormal electrocardiogram (ECG) finding within 14 days of enrollment
- Congestive heart failure (New York Heart Association Class III or IV)
- Myocardial infarction within 12 months prior to enrollment
- Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris
- Current or prior use of immunosuppressive medication within 14 days prior to enrollment, excluding:
- Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection)
- Systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., computed tomography scan premedication)
- Taken a strong inhibitor or inducer of CYP3A4/5 including grapefruit, St. John's Wort or related products within two weeks prior to dosing and during the study
- Positive test for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis A or C
- Prior therapy with iberdomide
- Unable or unwilling to undergo protocol required thromboembolism prophylaxis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Phase 2 Study of Iberdomide Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma
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.
Read the detailed description
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 is a phase II study to 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. Prior to each 28 day cycle, enrolled participants will have health evaluations, well-being assessment and lab tests. Blood and/or urine will be collected for routine tests, disease status and drug effects. Participants will take iberdomide pills by mouth at 1.0 mg PO daily on days 1-21 of each cycle. Treatment will continue until disease progression or toxicity. Participants on study drug at year 1 \& 2 will have bone marrow biopsies to assess the disease. Follow-up visits with similar testing will occur every 12 weeks until disease relapse or progression or another treatment for the disease is begun. Study objectives include determination of the proportion of participant completing one year of maintenance treatment, median progression free survival (PFS), minimal residual disease (MRD)-negativity rate at one year post-study drug initiation, sustained MRD-negativity rate, rate of conversion from MRD-positive to negative; overall survival (OS); and safety profile. The results from this study will inform the feasibility of pursuing a phase 3 study comparing iberdomide to lenalidomide maintenance post-ASCT.
- Conditions
- Multiple Myeloma
- Being tested
- Iberdomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IberdomideDrug
Also called cereblon E3 ligase modulator
Iberdomide is a novel potent cereblon E3 ligase modulator
| Study group | Role | What they receive |
|---|---|---|
| Iberdomide | Experimental | Iberdomide will be dosed at 1.0 mg orally daily on days 1-21 of a 28-day cycle Receives: Drug: Iberdomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (6)
Median Progression-free Survival
Progression-free survival (PFS) for all participants will be determined. This defined as the time from enrollment to documentation of disease progression, using 2016 International Myeloma Working Group (IMWG) Response Criteriacriteria, or death without disease progression.
Measured: 5 years
Minimal Residual Disease-negativity Rate at Day 100
An estimate of the Minimal Residual Disease (MRD)-negativity rate at day 100 post-initiation of maintenance therapy will be made.
Measured: 100 Days
Minimal Residual Disease-negativity Rate at One Year
An estimate of the Minimal Residual Disease (MRD)-negativity rate at one year post-initiation of maintenance therapy will be made.
Measured: 1 year
Minimal Residual Disease-negativity Rate at Two Years
An estimate of the Minimal Residual Disease (MRD)-negativity rate at two years post-initiation of maintenance therapy will be made.
Measured: 2 years
Sustained Minimal Residual Disease-negativity Rate
The sustained Minimal Residual Disease (MRD)-negativity rate, defined as MRD-negativity at study entry and at one year post-initiation of maintenance therapy will be determined.
Measured: 1 year
Rate of Conversion From Minimal Residual Disease-positive to Minimal Residual Disease-negative
The percentage of participants found to be Minimal Residual Disease (MRD) positive at enrollment and MRD negative at one year post-initiation of maintenance therapy among participants meeting the criteria for MRD-positivity at enrollment will be determined.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start14 Jun 2022
- Primary completion2 Jan 2026
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah A Holstein, MD, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177536
- Sponsor's protocol ID
- 0852-21-FB
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2021
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Iberdomide Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05177536
- Acronym / sponsor ID
- 0852-21-FB
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- Jan 2031 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 is a phase II study to 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. Prior to each 28 day cycle, enrolled participants will have health evaluations, well-being assessment and lab tests. Blood and/or urine will be collected for routine tests, disease status and drug effects. Participants will take iberdomide pills by mouth at 1.0 mg PO daily on days 1-21 of each cycle. Treatment will continue until disease progression or toxicity. Participants on study drug at year 1 \& 2 will have bone marrow biopsies to assess the disease. Follow-up visits with similar testing will occur every 12 weeks until disease relapse or progression or another treatment for the disease is begun. Study objectives include determination of the proportion of participant completing one year of maintenance treatment, median progression free survival (PFS), minimal residual disease (MRD)-negativity rate at one year post-study drug initiation, sustained MRD-negativity rate, rate of conversion from MRD-positive to negative; overall survival (OS); and safety profile. The results from this study will inform the feasibility of pursuing a phase 3 study comparing iberdomide to lenalidomide maintenance post-ASCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iberdomide | Experimental | Drug: IberdomideIberdomide will be dosed at 1.0 mg orally daily on days 1-21 of a 28-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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):
- Prior MM therapy
- 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
Key exclusion criteria (40 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IberdomideAlso: cereblon E3 ligase modulatorIberdomide is a novel potent cereblon E3 ligase modulator | Drug | Iberdomide |
Primary outcome
Proportion of Participants Able to Complete a Minimum of One Year of Ttherapy
Time frame: 1 year
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.
6 secondary outcomes
Median Progression-free Survival
Time frame: 5 years
Minimal Residual Disease-negativity Rate at Day 100
Time frame: 100 Days
Minimal Residual Disease-negativity Rate at One Year
Time frame: 1 year
Minimal Residual Disease-negativity Rate at Two Years
Time frame: 2 years
Sustained Minimal Residual Disease-negativity Rate
Time frame: 1 year
Rate of Conversion From Minimal Residual Disease-positive to Minimal Residual Disease-negative
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah A Holstein, MD, PhD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iberdomide in people with Multiple Myeloma, run by University of Nebraska at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Able to Complete a Minimum of One Year of Ttherapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.