Multiple MyelomaPhase 2NCT05354557
Study of Iberdomide in People With Multiple Myeloma Who Have Had an Autologous Hematopoietic Stem Cell Transplant (AHCT)
A Phase 2 study testing Iberdomide in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Iberdomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 8 sitesUnited States
- Study dates
- 26 Apr 2022to 26 Apr 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- A female of childbearing potential (FCBP) is a female who:
- has achieved menarche at some point
- has not undergone a hysterectomy or bilateral oophorectomy
- has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) and must:
- Have two negative pregnancy tests as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
- Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with 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 subjects must practice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg calendar, ovulation, symptothermal or post-ovulation methods] and withdrawal are not acceptable methods of contraception.) 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 he has undergone a successful vasectomy. Males 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. All subjects 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 subjects must follow all requirements defined in the Pregnancy Prevention Program.
- All subjects must:
- Understand that iberdomide could have potential teratogenic risk.
- Agree to abstain from donating blood while taking iberdomide and for 28 days following discontinuation of the iberdomide.
- Agree not to share iberdomide with another person.
- Other than the subject, FCBP and males able to father a child should not handle the IP or touch the capsules unless gloves are worn.
- Be counseled about pregnancy precautions and risks of fetal exposure as described in the Pregnancy Prevention Plan.
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Memorial Sloan Kettering Basking Ridge (Consent and Followup)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Suffolk-Commack (Consent and Follow up)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent and Follow Up)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent and Follow-Up only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent and Follow up)
Montvale, New Jersey, 07645
Weill Cornell Medical College (Data Collection Only)
New York, New York, 10021
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent and Followup)
Rockville Centre, New York, 11553
About this study
Official title: Phase II Multicenter Trial of Iberdomide as Maintenance Therapy for Multiple Myeloma Patients With Sub-Optimal Response After Autologous Hematopoietic Cell Transplantation or After Salvage Autologous Hematopoietic Cell Transplantation
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.
- Conditions
- Multiple Myeloma
- Being tested
- Iberdomide
- Keywords
- multiple myeloma, Autologous Hematopoietic Stem Cell Transplant, Stem Cell Transplant, AHCT, Iberdomide, 22-040, Memorial Sloan Kettering Cancer Center
- 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
Patients will receive 12 cycles of iberdomide as maintenance therapy. Cohort 1: Cycle 1-12: Iberdomide 1mg daily Days 1-21 of 28 day cycles Cohort 2: Cycles 1-12: Iberdomide 1mg daily Days 1-21 of 28 day cycles
| Study group | Role | What they receive |
|---|---|---|
| Single prior autoHCT with melphalan | Experimental | Participants have not experienced disease progression since initiation of initial systemic anti-myeloma therapy, are within 12 months of frontline autoHCT with
>/=140mg/m2 of melphalan, initiated lenalidomide maintenance at least 6 months ago, and have a very good partial response (VGPR) or less at time of enrollment. Cohort 1 will be initiated after evaluation of preliminary efficacy and safety data from Cohort 2. Receives: Drug: Iberdomide |
| 2 to 3 prior lines of systemic anti-myeloma therapy +/- prior autoHCT | Experimental | Participants have already received lenalidomide maintenance after a prior line of treatment, underwent a salvage autoHCT within the prior 2-6 months as consolidation therapy for relapsed disease after 2 to 3 prior therapies Receives: Drug: Iberdomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR) rate
Estimate the 6-month complete response (CR) rate after iberdomide in Multiple Myeloma patients with suboptimal disease responses after an autoHCT and lenalidomide maintenance or autoHCT performed in patients who had progressed on lenalidomide maintenance previously.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start26 Apr 2022
- Primary completion26 Apr 2027 (estimated)
- Study completion26 Apr 2027 (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 Memorial Sloan Kettering Cancer CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunjan Shaw, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354557
- Sponsor's protocol ID
- 22-040
- Status last verified
- Sep 2026
- First submitted
- 26 Apr 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Trial of Iberdomide as Maintenance Therapy for Multiple Myeloma Patients With Sub-Optimal Response After Autologous Hematopoietic Cell Transplantation or After Salvage Autologous Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT05354557
- Acronym / sponsor ID
- 22-040
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, Autologous Hematopoietic Stem Cell Transplant, Stem Cell Transplant, AHCT, Iberdomide, 22-040, Memorial Sloan Kettering Cancer Center
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 26 Apr 2027 (estimated)
- Study completion
- 26 Apr 2027 (estimated)
- First posted
- 29 Apr 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single prior autoHCT with melphalan | Experimental | Drug: IberdomideParticipants have not experienced disease progression since initiation of initial systemic anti-myeloma therapy, are within 12 months of frontline autoHCT with >/=140mg/m2 of melphalan, initiated lenalidomide maintenance at least 6 months ago, and have a very good partial response (VGPR) or less at time of enrollment. Cohort 1 will be initiated after evaluation of preliminary efficacy and safety data from Cohort 2. |
| 2 to 3 prior lines of systemic anti-myeloma therapy +/- prior autoHCT | Experimental | Drug: IberdomideParticipants have already received lenalidomide maintenance after a prior line of treatment, underwent a salvage autoHCT within the prior 2-6 months as consolidation therapy for relapsed disease after 2 to 3 prior therapies |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)
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 |
|---|---|---|
| IberdomidePatients will receive 12 cycles of iberdomide as maintenance therapy. Cohort 1: Cycle 1-12: Iberdomide 1mg daily Days 1-21 of 28 day cycles Cohort 2: Cycles 1-12: Iberdomide 1mg daily Days 1-21 of 28 day cycles | Drug | 2 to 3 prior lines of systemic anti-myeloma therapy +/- prior autoHCT, Single prior autoHCT with melphalan |
Primary outcome
Complete response (CR) rate
Time frame: 6 months
Estimate the 6-month complete response (CR) rate after iberdomide in Multiple Myeloma patients with suboptimal disease responses after an autoHCT and lenalidomide maintenance or autoHCT performed in patients who had progressed on lenalidomide maintenance previously.
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 29 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Gunjan Shaw, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 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 Memorial Sloan Kettering Cancer Center at 8 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 38 inclusion and 17 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Complete response (CR) rate (time frame: 6 months). 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 29 Sep 2026.