RECRUITING

Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Transplant Eligible Multiple Myeloma

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Phase I/II Study of Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Patients With Newly Diagnosed Transplant Eligible Multiple Myeloma

Quick Facts

Study Start:2022-05-13

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05199311

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Documented newly diagnosed multiple myeloma 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: 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: 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.	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

Inclusion Criteria

Exclusion Criteria

1. Documented newly diagnosed multiple myeloma
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:
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:
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.

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

Contacts and Locations

Study Contact

Palka Anand

CONTACT

551-996-3040

Palka.Anand@hmhn.org

Kristin Ivanovski

CONTACT

551-996-5231

Kristin.Ivanovski@hmhn.org

Principal Investigator

Noa Biran, MD

PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Study Locations (Sites)

Lombardi Comprehensive Cancer Center

Washington, District of Columbia, 20007

United States

John Theurer Cancer Center

Hackensack, New Jersey, 07601

United States

Collaborators and Investigators

Sponsor: Hackensack Meridian Health

Noa Biran, MD, PRINCIPAL_INVESTIGATOR, Hackensack Meridian Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-13

Study Completion Date2025-11

Study Record Updates

Study Start Date2022-05-13

Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

Multiple Myeloma