New drug cocktail aims to boost myeloma remission before transplant
NCT ID NCT05199311
First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times
Summary
This study tests a combination of three drugs—carfilzomib, iberdomide, and dexamethasone—in people newly diagnosed with multiple myeloma who are eligible for a stem cell transplant. The goal is to see if this mix is safe and effective at shrinking the cancer before transplant. About 66 participants will receive the drugs in cycles, and researchers will track side effects and remission rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- carfilzomib, iberdomide, and dexamethasone
- What this could lead to
- If successful, this combination could become a new initial treatment option for multiple myeloma patients before a stem cell transplant, potentially improving remission rates.
- What could go wrong
- This is an early-phase trial with only 66 participants, so results may not apply broadly. The drugs can cause serious side effects like heart or lung problems, and the combination may not prove more effective than existing therapies.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Documented newly diagnosed multiple myeloma a. At least 25% of patients accrued should be high risk as defined by IMWG or mSMART criteria. 2. Patient should be deemed transplant eligible. 3. Patients may not have had more than 1 cycle of prior induction therapy. If a patient has had 1 cycle of prior multiple myeloma therapy, the patient must have had documented measurable disease prior to initiation of cycle 1. 4. Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. 5. Subjects must have a documented diagnosis of MM and have measurable disease defined as: 1. M-protein (serum and/or urine protein electrophoresis (sPEP or uPEP)): sPEP≥0.5 g/dL or uPEP ≥ 200 mg/24 hours and/or 2. 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 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. 7. A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral salpingectomy, 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 in the preceding 24 consecutive months) and must: a. 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. 8. 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. 9. Male subjects must: a. 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 \[e.g. calendar, ovulation, symptothermal or post-ovulation methods\] 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 28 days following the last dose of iberdomide even he has undergone a successful vasectomy. 10. Males must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 28 days following last dose of study treatment. 11. 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. 12. All male and female subjects must follow all requirements defined in the Pregnancy Prevention Program. Note: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Exclusion Criteria: 1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 2. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 3. Subject has any condition that confounds the ability to interpret data from the study 4. Subject has nonsecretory multiple myeloma 5. Subjects with Plasma Cell leukemia or amyloidosis (with the exception of isolated marrow involvement). 6. Any of the following laboratory abnormalities: 1. Absolute neutrophil count (ANC) \< 1,000/μL 2. Platelet count \< 50,000/μL. It is not permissible to transfuse subjects to achieve minimum platelet counts. 3. Corrected serum calcium \> 13.5 mg/dL (\> 3.4 mmol/L) 4. Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) ≥ 2.5 x upper limit of normal (ULN) 5. Serum total bilirubin, direct bilirubin, or alkaline phosphatase ≥ 1.5 x ULN 6. Subjects with serious renal impairment (\[CrCl\] \< 30 mL/min) or requiring dialysis would be excluded 7. Subjects with peripheral neuropathy ≥ Grade 2 8. Subjects with gastrointestinal disease that may significantly alter the absorption of iberdomide 9. Subjects with a prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 3 years with the exception of the following noninvasive malignancies: 1. Basal cell carcinoma of the skin 2. Squamous cell carcinoma of the skin 3. Carcinoma in situ of the cervix 4. Carcinoma in situ of the breast 5. Incidental histological findings of prostate cancer such as T1a or T1b using the Tumor/Node/Metastasis (TNM) classification of malignant tumors or prostate cancer that is curative 10. Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide 11. Contraindications to the other treatment regimens, as per local prescribing information 12. Subject has received any of the following within the last 14 days of initiating IP: 1. Plasmapheresis 2. Major surgery (as defined by the Investigator) 3. Radiation therapy other than local therapy for MM associated bone lesions 4. Use of any systemic myeloma drug therapy 13. Subject has been treated with an investigational agent (ie, an agent not commercially available) within 28 days or 5 half-lives (whichever is longer) of initiating IP 14. Subject has any one of the following: 1. Active congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, screening ECG with corrected QT interval (QTc) of \> 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization. 2. Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris 3. Subject experienced a cardiac event within 6 months prior to the first dose of IP 15. Subject has current or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions to this criterion: 1. Intranasal, inhaled, topical or local steroid injections (eg, intra-articular injection) 2. Glucocorticoid therapy within 14 days prior to randomization that exceeds a cumulative dose of 160 mg of dexamethasone or equivalent dose of other corticosteroids. 3. Steroids as premedication for hypersensitivity reactions (eg, computed tomography \[CT\] scan premedication) 16. Subject has 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 course of study 17. Subject known to test positive for human immunodeficiency virus (HIV), uncontrolled or active viral hepatitis. 18. Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis 19. Subject is a female who is pregnant, nursing or breastfeeding, or who intends to become pregnant during the participation in the study, or who will not agree to comply with contraceptive requirements or pregnancy monitoring requirements 20. Left ventricular ejection fraction (LVEF) \< 40% as determined by echocardiogram (ECHO) 21. Prior use of iberdomide 22. Subject is pregnant 23. Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment. Uncontrolled hypertension is defined as: a subject whose blood pressure exceeds ≥ 160 mmHg systolic or ≥ 100 mmHg diastolic when taken in accordance with the European Society of Hypertension/European Society of Cardiology 2018 guidelines
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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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.
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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
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John Theurer Cancer Center
Hackensack, New Jersey, 07601, United States
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Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas