Multiple MyelomaPhase 2NCT06179888
Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma
A Phase 2 study testing Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Multiple Myeloma, run by National Cancer Institute (NCI) at 74 sites in United States.
Trial summary
This phase II trial compares iberdomide maintenance therapy to disease monitoring for improving survival in patients who have received idecabtagene vicleucel (a type of chimeric antigen receptor T-cell [CAR-T] therapy) for multiple myeloma. 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?
- Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 74 sitesUnited States
- Study dates
- 27 Aug 2024to 1 Mar 2030
- Phase
- Phase 2
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
- 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):
Show all 54Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
74 sites in 1 country.
74 sites in 1 country
United States74 sites
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Augusta University Medical Center
Augusta, Georgia, 30912
Houston Methodist San Jacinto Hospital
Baytown, Texas, 77521
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, 28210
Atrium Health University City/LCI-University
Charlotte, North Carolina, 28262
University of Illinois
Chicago, Illinois, 60612
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Memorial Sloan Kettering Commack
Commack, New York, 11725
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Houston Methodist Cypress Hospital
Cypress, Texas, 77429
Geisinger Medical Center
Danville, Pennsylvania, 17822
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Houston Methodist Hospital
Houston, Texas, 77030
Methodist Willowbrook Hospital
Houston, Texas, 77070
Houston Methodist West Hospital
Houston, Texas, 77094
Levine Cancer Institute - Huntersville
Huntersville, North Carolina, 28078
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Atrium Health Union/LCI-Union
Monroe, North Carolina, 28112
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Houston Methodist Saint John Hospital
Nassau Bay, Texas, 77058
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
University of Nebraska Medical Center
Omaha, Nebraska, 68198
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Washington University School of Medicine
St Louis, Missouri, 63110
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, 77479
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, 77385
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Randomized Phase 2 Study of Iberdomide Maintenance Therapy Following Idecabtagene Vicleucel CAR-T in Multiple Myeloma Patients
This phase II trial compares iberdomide maintenance therapy to disease monitoring for improving survival in patients who have received idecabtagene vicleucel (a type of chimeric antigen receptor T-cell [CAR-T] therapy) for multiple myeloma. The usual approach after treatment with idecabtagene vicleucel is to monitor the multiple myeloma without giving myeloma medications. There is currently no medication approved specifically for use after idecabtagene vicleucel treatment. Upon administration, iberdomide modifies the immune system and activates immune cells called T-cells, which could enhance the effectiveness of idecabtagene vicleucel. Iberdomide may keep multiple myeloma under control for longer than the usual approach (disease monitoring) after idecabtagene vicleucel, and may help multiple myeloma patients live longer.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish and confirm the safety and dose of iberdomide as maintenance after idecabtagene vicleucel (ide-cel) CAR-T. (Safety run-in) II. To assess whether iberdomide maintenance therapy after idecabtagene vicleucel CAR-T cell therapy increases progression-free survival (PFS) relative to observation without additional therapy. (Randomized phase II)
SECONDARY OBJECTIVES:
- To demonstrate anti-tumor activity, defined as conversion from non-minimal residual disease (MRD) complete response (CR)/stringent CR (sCR) status to MRD-negative CR/sCR, as well as improvement in PFS in the safety run-in cohort. (Safety run-in) II. To estimate the rate of conversion from MRD-positive at baseline to MRD-negative at any time point post-initiation of iberdomide maintenance or observation without additional therapy. (Key secondary objective; Randomized phase II) III. To estimate overall survival (OS) distribution post-initiation of iberdomide maintenance or observation without additional therapy. (Key secondary objective; Randomized phase II) IV. To estimate the minimal residual disease (MRD)-negativity rate at pre-registration and at one year post-initiation of iberdomide maintenance or observation without additional therapy. (Randomized phase II) V. To estimate rate of deepening hematological response among patients with measurable multiple myeloma (MM) post-initiation of iberdomide maintenance or observation without additional therapy. (Randomized phase II) VI. To evaluate the safety profile of iberdomide maintenance. (Randomized phase II) VII. To evaluate the peripheral blood immunophenotype before and during iberdomide maintenance or observation without additional therapy. (Randomized phase II) VIII. To evaluate persistence of CAR-T cells with iberdomide maintenance or observation without additional therapy. (Randomized phase II)
CORRELATIVE SCIENCE OBJECTIVES:
- To estimate the minimal residual disease (MRD)-negativity rate at start of maintenance and at one year post-initiation of maintenance or observation.
II. To estimate the sustained MRD-negativity rate. III. To estimate the rate of conversion from MRD-positive to MRD-negative. (Key objective) IV. To evaluate the peripheral blood immunophenotype before and during maintenance therapy or observation.
- To evaluate the persistence of CAR-T cells. VI. To evaluate B-cell maturation antigen (BCMA) protein expression by immunohistochemistry on myeloma cells from patients that have relapsed/recurrent disease.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients undergo disease monitoring at monthly clinic visits until disease progression. Patients also undergo bone marrow aspiration and biopsy throughout the trial, undergo collection of blood samples at screening and on study, and undergo positron emission tomography (PET)/computed tomography (CT) and/or skeletal survey x-ray, CT, or magnetic resonance imaging (MRI) at screening and then as clinically indicated.
GROUP 2: Patients receive iberdomide orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy throughout the trial, undergo collection of blood samples at screening and on study, and undergo PET/CT and/or skeletal survey x-ray, CT, or MRI at screening and then as clinically indicated.
After completion of study treatment, patients are followed up within 30 days, then every 3-6 months until 4 years following registration.
- Conditions
- Multiple Myeloma
- Being tested
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, 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.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow biopsy
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT and/or CT
IberdomideDrug
Also called CC 220, CC-220, Zenbexus
Given PO
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Patient MonitoringProcedure or surgery
Also called medical monitoring, monitor
Undergo disease monitoring
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
Skeletal Survey X-RayProcedure or surgery
Also called Skeletal Survey
Undergo skeletal survey x-ray
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (monitoring) | Active comparator | Patients undergo disease monitoring at monthly clinic visits until disease progression. Patients also undergo bone marrow aspiration and biopsy throughout the trial, undergo collection of blood samples at screening and on study, and undergo PET/CT and/or skeletal survey x-ray, CT, or MRI at screening and then as clinically indicated. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Patient Monitoring; Procedure: Positron Emission Tomography; Procedure: Skeletal Survey X-Ray |
| Group II (iberdomide) | Experimental | Patients receive iberdomide PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy throughout the trial, undergo collection of blood samples at screening and on study, and undergo PET/CT and/or skeletal survey x-ray, CT, or MRI at screening and then as clinically indicated. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Iberdomide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Skeletal Survey X-Ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (safety run-in)
Measured: The first 3 months of therapy
Progression-free survival (PFS) (randomized phase II)
Final analyses will use log-rank test statistics to compare the PFS distributions between the treatment arms. Will also evaluate differences in PFS between the treatment arms using a stratified log-rank test. In addition, the methods of Kaplan and Meier will be used to graphically evaluate these distributions as well as to estimate the median PFS and corresponding 95% confidence intervals. Further, will also estimate the 1- and 2-year PFS rates for each treatment arm along with corresponding 95% confidence intervals. Finally, Cox proportional hazards models will be used to evaluate the impact of treatment arm on PFS.
Measured: From randomization to the time of progression and/or death, assessed up to 4 years
Secondary outcomes (7)
Incidence of adverse events
Adverse events will be collected and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria. For CTCAE data, the maximum grade for each type of adverse will be recorded for each patient, and described using frequency tables. All-cause adverse events will be summarized as well as treatment-related adverse events, with particular focus on grade 3+ non-hematologic adverse events and grade 4+ hematologic events. Frequency tables will be reviewed to identify patterns. The overall adverse event severity will be compared between treatment arms using a chi-square test (or Fisher's exact test if the data in contingency table is sparse).
Measured: Up to 4 years
Number of treatment cycles received (tolerability)
Will be summarized.
Measured: Up to 4 years
Proportion of patients with dose modifications, omissions, and/or delays (tolerability)
Will be summarized.
Measured: Up to 4 years
Proportion of patients who go off treatment due to adverse events
Will be summarized.
Measured: Up to 4 years
Overall survival (OS)
The Kaplan-Meier method will be used to estimate OS for each treatment arm, with 1- and 2-year OS estimates and OS medians along with their 95% confidence intervals. For the comparison of the treatment arms, will use a one-sided log-rank test to compare the OS distributions between treatment arms. Will also evaluate the influence of arm on OS using stratified and unstratified multivariable Cox proportional hazards models.
Measured: From randomization until death from any cause, assessed up to 4 years
Best response achieved while on study
Will calculate these rates by treatment arm along with corresponding 95% binomial confidence intervals. Logistic regression models may also be used to assess differences in the ability to deepen or convert to a response between treatment arms. Minimal residual disease (MRD) will be assessed as an aspect of response assessment.
Measured: Up to 4 years
Proportion of patients who improve their status
Will calculate these rates by treatment arm along with corresponding 95% binomial confidence intervals. Logistic regression models may also be used to assess differences in the ability to deepen or convert to a response between treatment arms. MRD will be assessed as an aspect of response assessment.
Measured: After randomization, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start27 Aug 2024
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2030 (estimated)
Why it stopped: Scheduled Interim Monitoring
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 National Cancer Institute (NCI)The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sascha A Tuchman, Principal investigator, Alliance for Clinical Trials in Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179888
- Sponsor's protocol ID
- NCI-2023-10541
- Other IDs
- NCI-2023-10541, A062102, A062102, U10CA180821
- Status last verified
- Oct 2026
- First submitted
- 21 Dec 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: "NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page."