New drug may extend remission after CAR-T in myeloma

NCT ID NCT06179888

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 8 times

Summary

This phase 2 trial tests whether the drug iberdomide, taken after CAR-T therapy, can keep multiple myeloma under control longer than just monitoring. About 78 participants will be randomly assigned to receive iberdomide or standard monitoring. The study is currently suspended.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: iberdomide
What this could lead to: If it works, this could point toward a way to keep multiple myeloma in remission longer after CAR-T therapy.
What could go wrong: This trial is early (phase 2) and currently suspended, so results may not be available. Iberdomide may cause side effects and might not improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0): * All patients must be pre-registered. For patients who consent to biobanking, submit the bone marrow and blood specimens * Note: Patients who do not consent to the optional biobanking must be pre-registered, but specimens should not be submitted for these patients * Please ensure patient has suspected diagnosis of multiple myeloma and meets on study guidelines prior to informed consent and biospecimen collection * In cases where the bone marrow aspiration may be inadequate at Step 0 registration, the patient may still register on study * ELIGIBILITY CRITERIA (STEP 1): * Patients must have diagnostically confirmed MM in response status of stable disease or better by International Myeloma Working Group (IMWG) criteria at day 80-110 post-infusion of ide-cel. Patients in deep remission (e.g., CR, MRD-negative, etc.), are eligible * All patients are required to have received ide-cel CAR-T within 80-110 days of registration * Adverse events related to ide-cel are required to have resolved to grade =\< 1 except fatigue, alopecia, and other events that are unlikely to interfere with study assessments or pose a safety risk to participants * Patients must have had ≥ 2 lines of therapy for MM (this includes proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody) * Prior therapy with iberdomide is permitted but prior iberdomide refractoriness is prohibited. Refractoriness is defined as per published IMWG criteria; progression while on iberdomide or within 60 days of stopping iberdomide * Patients who have received MM-directed therapy since ide-cel infusion are not eligible, with the exception of short-course steroids for managing ide-cel toxicity as described below * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 * Platelet transfusions or use of growth factors for neutropenia (e.g., filgrastim, tbo-filgrastim, sagramostim) or thrombocytopenia (romiplostim or eltrombopag) are not permitted to meet enrollment criteria. Specific cutoffs are one week for short-acting myeloid growth factors for neutropenia, and two weeks for all platelet growth factors or long-acting (usually pegylated) myeloid growth factors * Platelet count ≥ 75,000/mm\^3 * Platelet transfusions or use of growth factors for neutropenia (e.g., filgrastim, tbo-filgrastim, sagramostim) or thrombocytopenia (romiplostim or eltrombopag) are not permitted to meet enrollment criteria. Specific cutoffs are one week for short-acting myeloid growth factors for neutropenia, and two weeks for all platelet growth factors or long-acting (usually pegylated) myeloid growth factors * Calculated (calc.) creatinine clearance \>= 30 mL/min by Modification of Diet in Renal Disease (MDRD) * Platelet transfusions or use of growth factors for neutropenia (e.g., filgrastim, tbo-filgrastim, sagramostim) or thrombocytopenia (romiplostim or eltrombopag) are not permitted to meet enrollment criteria. Specific cutoffs are one week for short-acting myeloid growth factors for neutropenia, and two weeks for all platelet growth factors or long-acting (usually pegylated) myeloid growth factors * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * Platelet transfusions or use of growth factors for neutropenia (e.g., filgrastim, tbo-filgrastim, sagramostim) or thrombocytopenia (romiplostim or eltrombopag) are not permitted to meet enrollment criteria. Specific cutoffs are one week for short-acting myeloid growth factors for neutropenia, and two weeks for all platelet growth factors or long-acting (usually pegylated) myeloid growth factors * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 x upper limit of normal (ULN) * Platelet transfusions or use of growth factors for neutropenia (e.g., filgrastim, tbo-filgrastim, sagramostim) or thrombocytopenia (romiplostim or eltrombopag) are not permitted to meet enrollment criteria. Specific cutoffs are one week for short-acting myeloid growth factors for neutropenia, and two weeks for all platelet growth factors or long-acting (usually pegylated) myeloid growth factors * Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown. * FCBP (female of childbearing potential) is a female who: 1) has achieved menarche (first menstrual cycle) at some point, 2) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 3) 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 during the preceding 24 consecutive months). * Females of childbearing potential (FCBP): * Must use a contraceptive method that is highly effective (with a failure rate of \< 1% per year), preferably with low user dependency during the intervention period and for at least 28 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. * The effects of iberdomide on the developing human fetus are unknown. Immunodulatory derivative (IMiD) agents as well as other therapeutic agents used in this trial are known to be teratogenic. Females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to, and again within 24 hours of starting iberdomide, and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking iberdomide. Examples of highly effective methods are intrauterine device, hormonal contraceptives, tubal ligation, or partner's vasectomy. Examples of barrier method are male condom, diaphragm, or cervical cap. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risk of fetal exposure. * Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. FCBP must use adequate contraception for at least 28 days after discontinuation from study. Because of the potential for serious adverse reactions in a breastfed child, women are advised not to breastfeed during treatment and for at least 28 days after the last dose. * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy. * Non-childbearing potential is defined as follows (by other than medical reasons): * ≥ 45 years of age and has not had menses for \> 1 year * Patients who have been amenorrhoeic for \< 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure * Male patients must agree to use an adequate method of contraception for the duration of the study and for 28 days afterwards. * Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies: * Male participants are eligible to participate if they agree to the following during the intervention period and for 28 days after the last dose of study treatment to allow for clearance of any altered sperm: * Refrain from donating sperm PLUS, either: * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR * Must agree to use contraception/barrier as detailed below: * Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \< 1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females) * Patients may not have polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome or amyloidosis involving any vital organ; amyloidosis found in skin or lymph nodes ("non-vital organs"), or incidental observation of amyloidosis on bone marrow biopsy, are both permissible. Plasma cell leukemia is permissible for study enrollment * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load * Patients may not have other, active infections at time of study registration. Recent infections are not exclusionary if antibiotics have been completed and infection is considered to be resolved / controlled. (Chronic maintenance antibiotics for prior infections, such as fungal, are permissible.) * No known allergy to iberdomide * No known medical condition causing an inability to swallow oral formulations of agents * Patients receiving other active therapies for MM since ide-cel infusion are prohibited from participating in the study * Corticosteroids used for the purpose of managing ide-cel toxicity (often neurotoxicity) soon after ide-cel administration are acceptable, provided that the participant will have been off corticosteroids for \> 30 days by cycle 1 day 1. Physiologically dosed chronic steroids are permitted * Given the potential for interaction with iberdomide, patients who take strong CYP3A4 inducers or inhibitors may enroll after switching to a different agent and after an appropriate washout period for that particular medication, ideally three half-lives, prior to cycle 1 day 1

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

74 sites. The list below names each one and where it is.
The official record

The full official record for this study. This one lists no contact details, but it is the first place any would appear.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, 28025, United States
Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, 28210, United States
Atrium Health Union/LCI-Union

Monroe, North Carolina, 28112, United States
Atrium Health University City/LCI-University

Charlotte, North Carolina, 28262, United States
Augusta University Medical Center

Augusta, Georgia, 30912, United States
Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143, United States
Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States
Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142, United States
Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209, United States
Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226, United States
Aurora Cancer Care-Racine

Racine, Wisconsin, 53406, United States
Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105, United States
Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022, United States
Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States
Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Aurora Saint Luke's South Shore

Cudahy, Wisconsin, 53110, United States
Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States
Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States
Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States
Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States
Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
Houston Methodist Cypress Hospital

Cypress, Texas, 77429, United States
Houston Methodist Hospital

Houston, Texas, 77030, United States
Houston Methodist Saint John Hospital

Nassau Bay, Texas, 77058, United States
Houston Methodist San Jacinto Hospital

Baytown, Texas, 77521, United States
Houston Methodist Sugar Land Hospital

Sugar Land, Texas, 77479, United States
Houston Methodist The Woodlands Hospital

The Woodlands, Texas, 77385, United States
Houston Methodist West Hospital

Houston, Texas, 77094, United States
Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States
Levine Cancer Institute - Huntersville

Huntersville, North Carolina, 28078, United States
Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Memorial Sloan Kettering Commack

Commack, New York, 11725, United States
Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States
Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States
Methodist Willowbrook Hospital

Houston, Texas, 77070, United States
Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123, United States
Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118, United States
Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States
Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States
Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, United States
Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States
Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States
Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026, United States
Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States
Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Vermont Medical Center

Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States
Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States
Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States

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