Multiple MyelomaPhase 1/2NCT05199311
Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Transplant Eligible Multiple Myeloma
A Phase 1/2 study testing Carfilzomib, Iberdomide and Oral Dexamethasone in people with Multiple Myeloma, run by Hackensack Meridian Health at 2 sites in United States.
Trial summary
This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM. 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?
- Carfilzomib, Iberdomide and Oral Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2022to Mar 2027
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Documented newly diagnosed multiple myeloma
- At least 25% of patients accrued should be high risk as defined by IMWG or mSMART criteria.
- Patient should be deemed transplant eligible.
- 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.
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
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- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subjects must have a documented diagnosis of MM and have measurable disease defined as:
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
- 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:
- 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:
- 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.
- 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.
- 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.
- 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.
Who cannot join
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- 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
- Subject has any condition that confounds the ability to interpret data from the study
- Subject has nonsecretory multiple myeloma
- Subjects with Plasma Cell leukemia or amyloidosis (with the exception of isolated marrow involvement).
- Any of the following laboratory abnormalities:
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- Absolute neutrophil count (ANC) < 1,000/μL
- Platelet count < 50,000/μL. It is not permissible to transfuse subjects to achieve minimum platelet counts.
- 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) ≥ 2.5 x upper limit of normal (ULN)
- Serum total bilirubin, direct bilirubin, or alkaline phosphatase ≥ 1.5 x ULN
- Subjects with serious renal impairment ([CrCl] < 30 mL/min) or requiring dialysis would be excluded
- Subjects with peripheral neuropathy ≥ Grade 2
- Subjects with gastrointestinal disease that may significantly alter the absorption of iberdomide
- 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:
- 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 as T1a or T1b using the Tumor/Node/Metastasis (TNM) classification of malignant tumors or prostate cancer that is curative
- Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide
- Contraindications to the other treatment regimens, as per local prescribing information
- Subject has received any of the following within the last 14 days of initiating IP:
- Plasmapheresis
- Major surgery (as defined by the Investigator)
- Radiation therapy other than local therapy for MM associated bone lesions
- Use of any systemic myeloma drug therapy
- 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
- Subject has any one of the following:
- 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.
- Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris
- Subject experienced a cardiac event within 6 months prior to the first dose of IP
- 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:
- Intranasal, inhaled, topical or local steroid injections (eg, intra-articular injection)
- Glucocorticoid therapy within 14 days prior to randomization that exceeds a cumulative dose of 160 mg of dexamethasone or equivalent dose of other corticosteroids.
- Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication)
- 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
- Subject known to test positive for human immunodeficiency virus (HIV), uncontrolled or active viral hepatitis.
- Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis
- 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
- Left ventricular ejection fraction (LVEF) < 40% as determined by echocardiogram (ECHO)
- Prior use of iberdomide
- Subject is pregnant
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase I/II Study of Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Patients With Newly Diagnosed Transplant Eligible Multiple Myeloma
This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM.
Read the detailed description
This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM.
As part of a dose escalation phase, the first 10 patients will be enrolled at dose level -1 (Iberdomide 1.1 mg po daily days 1-21). Two months after the first 10 patients have completed at least 2 cycles of therapy in dose level -1, an Independent Safety Review Committee will review the safety data. Assuming the combination is determined to have adequate safety and tolerability, 10 patients will be enrolled at dose level 1 (Iberdomide 1.3 mg po daily days 1-21). After an independent safety review two months after 10 patients have completed at least 2 cycles of therapy in dose level 1, the remaining 46 patients will be enrolled at dose level 2 (Iberdomide 1.6 mg po daily days 1-21).
Treatment will continue for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until disease progression or the start of a new line of therapy.
- Conditions
- Multiple Myeloma
- Being tested
- Carfilzomib, Iberdomide, Oral Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarfilzomibDrug
20 mg/m2 C1D1; 56 mg/m2 thereafter
IberdomideDrug
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
Oral DexamethasoneDrug
40 mg (<=75 years old); 20 mg (>75 years old)
| Study group | Role | What they receive |
|---|---|---|
| Starting Dose -1 | Experimental | CC-220/Iberdomide: 1.1 mg [CC-220 dosing schedule: daily for 21 days of each 28-day cycle]
Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter [Days 1, 8, 15 per 28-day cycle]
Dexamethasone: 40 mg (≤ 75 years) 20 mg (> 75 years) [Days 1, 8, 15, 22 per 28-day cycle]
Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy. Receives: Drug: Carfilzomib; Drug: Iberdomide; Drug: Oral Dexamethasone |
| Dose Level 1 | Experimental | CC-220/Iberdomide: 1.3 mg [CC-220 dosing schedule: daily for 21 days of each 28-day cycle]
Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter [Days 1, 8, 15 per 28-day cycle]
CC-220 dose level 1 enrollment will occur following an independent safety review two months after the first 10 patients have completed at least 2 cycles of therapy at dose level -1.
Dexamethasone: 40 mg (≤ 75 years) 20 mg (> 75 years) [Days 1, 8, 15, 22 per 28-day cycle]
Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy. Receives: Drug: Carfilzomib; Drug: Iberdomide; Drug: Oral Dexamethasone |
| Dose Level 2 | Experimental | CC-220/Iberdomide: 1.6 mg [CC-220 dosing schedule: daily for 21 days of each 28-day cycle]
Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter [Days 1, 8, 15 per 28-day cycle]
CC-220 dose level 2 enrollment will occur following an independent safety review two months after the first 10 patients have completed at least 2 cycles of therapy at dose level 1.
Dexamethasone: 40 mg (≤ 75 years) 20 mg (> 75 years) [Days 1, 8, 15, 22 per 28-day cycle]
Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy. Receives: Drug: Carfilzomib; Drug: Iberdomide; Drug: Oral Dexamethasone |
| Dose Level -2 | Experimental | CC-220/Iberdomide: 0.75 mg [CC-220 dosing schedule: daily for 21 days of each 28-day cycle]
Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter [Days 1, 8, 15 per 28-day cycle]
Dexamethasone: 40 mg (≤ 75 years) 20 mg (> 75 years) [Days 1, 8, 15, 22 per 28-day cycle]
Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy. Receives: Drug: Carfilzomib; Drug: Iberdomide; Drug: Oral Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of treatment emergent adverse events (TEAEs)
Rate of patients with treatment emergent adverse events (TEAEs) overall and per dose level
Measured: Measured after cycle 4 of induction KID (each cycle is 28 days)
CR and sCR
Evaluation of the rate of complete remission (CR) + stringent complete (sCR) remission for patients receiving 2-4 cycles of the combination of KID followed by ASCT in patients with newly diagnosed MM.
Measured: Measured after cycle 4 of induction KID (each cycle is 28 days)
Secondary outcomes (3)
Overall Response Rate (ORR)
Assessment of overall response rate (ORR) of newly diagnosed transplant-eligible MM patients.
Measured: Participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. On treatment study duration will last up to 12 months; Post treatment follow up will last up to two years.
Progression Free Survival (PFS)
Assessment of progression-free survival (PFS) of newly diagnosed transplant-eligible MM patients.
Measured: Participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. On treatment study duration will last up to 12 months; Post treatment follow up will last up to two years.
Overall Survival (OS)
Assessment of overall survival (OS) of newly diagnosed transplant-eligible MM patients.
Measured: Participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. On treatment study duration will last up to 12 months; Post treatment follow up will last up to two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start13 May 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Why it stopped: Temporary Hold Pending Amendment Approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (109)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noa Biran, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199311
- Sponsor's protocol ID
- Pro2021-0842
- Status last verified
- Jul 2026
- First submitted
- 3 Nov 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Agarwal A, Chow E, Bhutani M, Voorhees PM, Friend R, Usmani SZ. Practical Considerations in Managing Relapsed Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2017 Feb;17(2):69-77. doi: 10.1016/j.clml.2016.11.010. Epub 2016 Nov 23.
PubMed 27986429Ali SA, Shi V, Maric I, Wang M, Stroncek DF, Rose JJ, Brudno JN, Stetler-Stevenson M, Feldman SA, Hansen BG, Fellowes VS, Hakim FT, Gress RE, Kochenderfer JN. T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of multiple myeloma. Blood. 2016 Sep 29;128(13):1688-700. doi: 10.1182/blood-2016-04-711903. Epub 2016 Jul 13.
PubMed 27412889Amatangelo M, Bjorklund CC, Kang J, Polonskaia A, Viswanatha S, Thakurta A. Iberdomide (CC-220) has Synergistic Anti-Multiple Myeloma Activity in Combination with both Bortezomib and Dexamethasone, or in combination with Daratumumab in vitro. Blood. 2018;132(Suppl 1):1935.
Avet-Loiseau H, Casneuf T, Chiu C, Laubach J, Lee J, Moreau P, et al. Evaluation of Minimal Residual Disease (MRD) in Relapsed/Refractory Multiple Myeloma (RRMM) Patients Treated with Daratumumab in Combination with Lenalidomide Plus Dexamethasone or Bortezomib Plus Dexamethasone. Blood. 2016; 128(22):246.
Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551.
PubMed 25184863Berdeja J, Lin Y, Raje N, Munshi N, Siegel D, Liedtke M, et al. Durable Clinical Responses in Heavily Pretreated Patients with Relapsed/Refractory Multiple Myeloma: Updated Results from a Multicenter Study of bb2121 Anti-Bcma CAR T Cell Therapy. Blood. 2017; 130 (Suppl 1): 740.
Biran N, Siegel D, Berdeja JG, Raje N, Cornell RF, Alsina M, Kovacsovics T, Fang B, Kimball AS, Landgren O. Weekly carfilzomib, lenalidomide, and dexamethasone in relapsed or refractory multiple myeloma: A phase 1b study. Am J Hematol. 2019 Jul;94(7):794-802. doi: 10.1002/ajh.25498. Epub 2019 May 13.
PubMed 31021005Bjorklund C, Kang J, Lu L, Amatangelo M, Chiu H, Hagner P, et al. CC-122 Is a Cereblon Modulating Agent That Is Active in Lenalidomide-Resistant and Lenalidomide/DexamethasoneDouble-Resistant Multiple Myeloma Pre-Clinical Models. Blood. 2016;128(Suppl 1):1592.
Botta C, Ciliberto D, Rossi M, Staropoli N, Cuce M, Galeano T, Tagliaferri P, Tassone P. Network meta-analysis of randomized trials in multiple myeloma: efficacy and safety in relapsed/refractory patients. Blood Adv. 2017 Feb 27;1(7):455-466. doi: 10.1182/bloodadvances.2016003905. eCollection 2017 Feb 28.
PubMed 29296961Brudno JN, Maric I, Hartman SD, Rose JJ, Wang M, Lam N, Stetler-Stevenson M, Salem D, Yuan C, Pavletic S, Kanakry JA, Ali SA, Mikkilineni L, Feldman SA, Stroncek DF, Hansen BG, Lawrence J, Patel R, Hakim F, Gress RE, Kochenderfer JN. T Cells Genetically Modified to Express an Anti-B-Cell Maturation Antigen Chimeric Antigen Receptor Cause Remissions of Poor-Prognosis Relapsed Multiple Myeloma. J Clin Oncol. 2018 Aug 1;36(22):2267-2280. doi: 10.1200/JCO.2018.77.8084. Epub 2018 May 29.
PubMed 29812997Chari A, Rodriguez-Otero P, McCarthy H, Suzuki K, Hungria V, Sureda Balari A, Perrot A, Hulin C, Magen H, Iida S, Maisnar V, Karlin L, Pour L, Parasrampuria DA, Masterson T, Kosh M, Yang S, Delioukina M, Qi M, Carson R, Touzeau C. Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open-label Phase II study. Br J Haematol. 2021 Mar;192(5):869-878. doi: 10.1111/bjh.16980. Epub 2020 Jul 30.
PubMed 33216361Cowan AJ, Allen C, Barac A, Basaleem H, Bensenor I, Curado MP, Foreman K, Gupta R, Harvey J, Hosgood HD, Jakovljevic M, Khader Y, Linn S, Lad D, Mantovani L, Nong VM, Mokdad A, Naghavi M, Postma M, Roshandel G, Shackelford K, Sisay M, Nguyen CT, Tran TT, Xuan BT, Ukwaja KN, Vollset SE, Weiderpass E, Libby EN, Fitzmaurice C. Global Burden of Multiple Myeloma: A Systematic Analysis for the Global Burden of Disease Study 2016. JAMA Oncol. 2018 Sep 1;4(9):1221-1227. doi: 10.1001/jamaoncol.2018.2128.
PubMed 29800065Cho SF, Anderson KC, Tai YT. Targeting B Cell Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based Immunotherapy. Front Immunol. 2018 Aug 10;9:1821. doi: 10.3389/fimmu.2018.01821. eCollection 2018.
PubMed 30147690Darzalex. [Package Insert]. Horsham, PA: Janssen Biotech. Available from: https://www.janssenmd.com/pdf/darzalex/darzalex_pi.pdf.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Patients With Newly Diagnosed Transplant Eligible Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05199311
- Acronym / sponsor ID
- Pro2021-0842
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporary Hold Pending Amendment Approval
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 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.
This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM.
Detailed description
This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM.
As part of a dose escalation phase, the first 10 patients will be enrolled at dose level -1 (Iberdomide 1.1 mg po daily days 1-21). Two months after the first 10 patients have completed at least 2 cycles of therapy in dose level -1, an Independent Safety Review Committee will review the safety data. Assuming the combination is determined to have adequate safety and tolerability, 10 patients will be enrolled at dose level 1 (Iberdomide 1.3 mg po daily days 1-21). After an independent safety review two months after 10 patients have completed at least 2 cycles of therapy in dose level 1, the remaining 46 patients will be enrolled at dose level 2 (Iberdomide 1.6 mg po daily days 1-21).
Treatment will continue for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until disease progression or the start of a new line of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Starting Dose -1 | Experimental | Drug: Carfilzomib, Drug: Iberdomide, Drug: Oral DexamethasoneCC-220/Iberdomide: 1.1 mg [CC-220 dosing schedule: daily for 21 days of each 28-day cycle] Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter [Days 1, 8, 15 per 28-day cycle] Dexamethasone: 40 mg (≤ 75 years) 20 mg (> 75 years) [Days 1, 8, 15, 22 per 28-day cycle] Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy. |
| Dose Level 1 | Experimental | Drug: Carfilzomib, Drug: Iberdomide, Drug: Oral DexamethasoneCC-220/Iberdomide: 1.3 mg [CC-220 dosing schedule: daily for 21 days of each 28-day cycle] Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter [Days 1, 8, 15 per 28-day cycle] CC-220 dose level 1 enrollment will occur following an independent safety review two months after the first 10 patients have completed at least 2 cycles of therapy at dose level -1. Dexamethasone: 40 mg (≤ 75 years) 20 mg (> 75 years) [Days 1, 8, 15, 22 per 28-day cycle] Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy. |
| Dose Level 2 | Experimental | Drug: Carfilzomib, Drug: Iberdomide, Drug: Oral DexamethasoneCC-220/Iberdomide: 1.6 mg [CC-220 dosing schedule: daily for 21 days of each 28-day cycle] Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter [Days 1, 8, 15 per 28-day cycle] CC-220 dose level 2 enrollment will occur following an independent safety review two months after the first 10 patients have completed at least 2 cycles of therapy at dose level 1. Dexamethasone: 40 mg (≤ 75 years) 20 mg (> 75 years) [Days 1, 8, 15, 22 per 28-day cycle] Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy. |
| Dose Level -2 | Experimental | Drug: Carfilzomib, Drug: Iberdomide, Drug: Oral DexamethasoneCC-220/Iberdomide: 0.75 mg [CC-220 dosing schedule: daily for 21 days of each 28-day cycle] Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter [Days 1, 8, 15 per 28-day cycle] Dexamethasone: 40 mg (≤ 75 years) 20 mg (> 75 years) [Days 1, 8, 15, 22 per 28-day cycle] Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Documented newly diagnosed multiple myeloma
- Patient should be deemed transplant eligible.
- 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.
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subjects must have a documented diagnosis of MM and have measurable disease defined as:
Key exclusion criteria (44 listed)
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- 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
- Subject has any condition that confounds the ability to interpret data from the study
- Subject has nonsecretory multiple myeloma
- Subjects with Plasma Cell leukemia or amyloidosis (with the exception of isolated marrow involvement).
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 |
|---|---|---|
| Carfilzomib20 mg/m2 C1D1; 56 mg/m2 thereafter | Drug | Dose Level -2, Dose Level 1, Dose Level 2, Starting Dose -1 |
| IberdomideOral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle | Drug | Dose Level -2, Dose Level 1, Dose Level 2, Starting Dose -1 |
| Oral Dexamethasone40 mg (<=75 years old); 20 mg (>75 years old) | Drug | Dose Level -2, Dose Level 1, Dose Level 2, Starting Dose -1 |
Primary outcome
Rate of treatment emergent adverse events (TEAEs)
Time frame: Measured after cycle 4 of induction KID (each cycle is 28 days)
Rate of patients with treatment emergent adverse events (TEAEs) overall and per dose level
CR and sCR
Time frame: Measured after cycle 4 of induction KID (each cycle is 28 days)
Evaluation of the rate of complete remission (CR) + stringent complete (sCR) remission for patients receiving 2-4 cycles of the combination of KID followed by ASCT in patients with newly diagnosed MM.
3 secondary outcomes
Overall Response Rate (ORR)
Time frame: Participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. On treatment study duration will last up to 12 months; Post treatment follow up will last up to two years.
Progression Free Survival (PFS)
Time frame: Participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. On treatment study duration will last up to 12 months; Post treatment follow up will last up to two years.
Overall Survival (OS)
Time frame: Participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. On treatment study duration will last up to 12 months; Post treatment follow up will last up to two years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 8433390Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
- Background: PubMed 27986429Agarwal A, Chow E, Bhutani M, Voorhees PM, Friend R, Usmani SZ. Practical Considerations in Managing Relapsed Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2017 Feb;17(2):69-77. doi: 10.1016/j.clml.2016.11.010. Epub 2016 Nov 23.
- Background: PubMed 27412889Ali SA, Shi V, Maric I, Wang M, Stroncek DF, Rose JJ, Brudno JN, Stetler-Stevenson M, Feldman SA, Hansen BG, Fellowes VS, Hakim FT, Gress RE, Kochenderfer JN. T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of multiple myeloma. Blood. 2016 Sep 29;128(13):1688-700. doi: 10.1182/blood-2016-04-711903. Epub 2016 Jul 13.
- BackgroundAmatangelo M, Bjorklund CC, Kang J, Polonskaia A, Viswanatha S, Thakurta A. Iberdomide (CC-220) has Synergistic Anti-Multiple Myeloma Activity in Combination with both Bortezomib and Dexamethasone, or in combination with Daratumumab in vitro. Blood. 2018;132(Suppl 1):1935.
- BackgroundAvet-Loiseau H, Casneuf T, Chiu C, Laubach J, Lee J, Moreau P, et al. Evaluation of Minimal Residual Disease (MRD) in Relapsed/Refractory Multiple Myeloma (RRMM) Patients Treated with Daratumumab in Combination with Lenalidomide Plus Dexamethasone or Bortezomib Plus Dexamethasone. Blood. 2016; 128(22):246.
- Background: PubMed 25184863Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551.
- BackgroundBerdeja J, Lin Y, Raje N, Munshi N, Siegel D, Liedtke M, et al. Durable Clinical Responses in Heavily Pretreated Patients with Relapsed/Refractory Multiple Myeloma: Updated Results from a Multicenter Study of bb2121 Anti-Bcma CAR T Cell Therapy. Blood. 2017; 130 (Suppl 1): 740.
- Background: PubMed 31021005Biran N, Siegel D, Berdeja JG, Raje N, Cornell RF, Alsina M, Kovacsovics T, Fang B, Kimball AS, Landgren O. Weekly carfilzomib, lenalidomide, and dexamethasone in relapsed or refractory multiple myeloma: A phase 1b study. Am J Hematol. 2019 Jul;94(7):794-802. doi: 10.1002/ajh.25498. Epub 2019 May 13.
- BackgroundBjorklund C, Kang J, Lu L, Amatangelo M, Chiu H, Hagner P, et al. CC-122 Is a Cereblon Modulating Agent That Is Active in Lenalidomide-Resistant and Lenalidomide/DexamethasoneDouble-Resistant Multiple Myeloma Pre-Clinical Models. Blood. 2016;128(Suppl 1):1592.
- Background: PubMed 29296961Botta C, Ciliberto D, Rossi M, Staropoli N, Cuce M, Galeano T, Tagliaferri P, Tassone P. Network meta-analysis of randomized trials in multiple myeloma: efficacy and safety in relapsed/refractory patients. Blood Adv. 2017 Feb 27;1(7):455-466. doi: 10.1182/bloodadvances.2016003905. eCollection 2017 Feb 28.
- Background: PubMed 29812997Brudno JN, Maric I, Hartman SD, Rose JJ, Wang M, Lam N, Stetler-Stevenson M, Salem D, Yuan C, Pavletic S, Kanakry JA, Ali SA, Mikkilineni L, Feldman SA, Stroncek DF, Hansen BG, Lawrence J, Patel R, Hakim F, Gress RE, Kochenderfer JN. T Cells Genetically Modified to Express an Anti-B-Cell Maturation Antigen Chimeric Antigen Receptor Cause Remissions of Poor-Prognosis Relapsed Multiple Myeloma. J Clin Oncol. 2018 Aug 1;36(22):2267-2280. doi: 10.1200/JCO.2018.77.8084. Epub 2018 May 29.
- Background: PubMed 33216361Chari A, Rodriguez-Otero P, McCarthy H, Suzuki K, Hungria V, Sureda Balari A, Perrot A, Hulin C, Magen H, Iida S, Maisnar V, Karlin L, Pour L, Parasrampuria DA, Masterson T, Kosh M, Yang S, Delioukina M, Qi M, Carson R, Touzeau C. Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open-label Phase II study. Br J Haematol. 2021 Mar;192(5):869-878. doi: 10.1111/bjh.16980. Epub 2020 Jul 30.
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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.
Noa Biran, MD principal investigator
Hackensack Meridian Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Carfilzomib, Iberdomide and Oral Dexamethasone in people with Multiple Myeloma, run by Hackensack Meridian Health 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 21 inclusion and 44 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: paused, as of the sponsor's last update on 13 Jul 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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?
Rate of treatment emergent adverse events (TEAEs) (time frame: Measured after cycle 4 of induction KID (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05199311, which also lists 109 linked publications.
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 13 Jul 2026.