Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Plasma Cell Myeloma

In brief

This phase I/II trial studies the side effects and best dose of iberdomide and how well it works in combination with daratumumab, bortezomib, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving iberdomide in combination with daratumumab, bortezomib, and dexamethasone may kill more cancer cells in patients with newly diagnosed multiple myeloma.

Key facts

Study ID

NCT05392946

Run by

Mayo Clinic

People needed

49

Starts

2022-08-11

Expected to finish

2028-09-29

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >= 18 years at the time of signing the informed consent form (ICF)
• Previously untreated active/symptomatic multiple myeloma or have received no more than one cycle of any anti-myeloma treatment regimen for active/symptomatic myeloma
• NOTE: Prior radiation therapy for the treatment of solitary plasmacytoma is permitted. Prior therapy with clarithromycin, dehydroepiandrosterone (DHEA), anakinra, pamidronate or zoledronic acid is permitted. Any additional agents not listed must be approved by the principal investigator
• Measurable disease
• Serum M-protein ≥0.5 g/dL
• Urine M-protein ≥200 mg in a 24-hour collection
• Serum Free Light Chain level ≥ 10 mg/dL provided the free light chain ratio is abnormal
• Measurable plasmacytoma [at least one lesion that has a single diameter of ≥2 cm on positron emission tomography (PET)-computed tomography (CT) scan]
• Bone marrow plasma cells≥30%
• Patients with IgA myeloma in whom serum protein electrophoresis is deemed unreliable, due to co-migration of normal serum proteins with the para protein in the beta region, may be considered eligible as long as total serum IgA level is elevated above normal range.
• For patients with extramedullary disease (EMD) measurable by CT or MRI or the CT portion of the PET/CT: Must have at least one lesion that has a single diameter of ≥2 cm. Skin lesions can be used if the area is ≥2cm in at least one diameter and measured with a ruler.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Hemoglobin >= 8.0 g/dL (obtained =< 14 days prior to registration)
• Absolute neutrophil count (ANC) >= 1000/mm\^3 (obtained =< 14 days prior to registration)
• Platelet count >= 75,000/mm\^3 (obtained =< 14 days prior to registration)
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (Exception for Gilbert's syndrome) (obtained =< 14 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 2 x ULN and alkaline phosphatase =< 1.5 x ULN (obtained =< 14 days prior to registration)
• Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained =< 14 days prior to registration)
• Calculated creatinine clearance >= 50 ml/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration)
• Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only. Note: A person of childbearing potential (PCBP) is a person who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) and must:
• Have 2 negative pregnancy tests as verified by the Investigator prior to starting study treatment and 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. AND
• 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, and for at least 28 days after the last dose of Iberdomide (90 days after the last dose of daratumumab, 7 months after last dose of bortezomib whichever is longer).
• NOTE: Non-childbearing potential is defined as follows (by other than medical reasons):
• >= 45 years of age and has not had menses for > 24 months
• 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

You may not qualify if…

• Monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis
• Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
• Pregnant persons
• Nursing persons
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Receiving any other concurrent chemotherapy, or any ancillary therapy considered investigational
• NOTE: Bisphosphonates are considered to be supportive care rather than therapy and are thus allowed while on protocol treatment
• Known to be human immunodeficiency virus (HIV) positive, known or suspected active hepatitis C infection or seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]) at screening or within 3 months prior to first dose of study treatment.
• NOTE: Participants with resolved hepatitis B infection (i.e.., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded.
• EXCEPTION: subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
• Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection (defined as infection undergoing treatment)
• Active mucosal or internal bleeding,
• Social situations that would limit compliance with study requirements (including drug addiction)
• Known gastrointestinal disease (including difficulty swallowing) or gastrointestinal procedure that could interfere with the oral absorption or tolerance of iberdomide or dexamethasone
• Unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria
• Active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). NOTE: Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil inclusion criteria
• Evidence of cardiovascular disease risk, as defined by any of the following:
• Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block
• History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of Screening
• Class III or IV heart failure as defined by the New York Heart Association functional classification system
• Uncontrolled hypertension
• History of life-threatening ventricular arrhythmias
• Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal. Note that forced expiratory testing (FEV1) is required for subjects suspected of having COPD and subjects must be excluded if FEV1 is < 50% of predicted normal
• Known moderate or severe persistent asthma, or currently has uncontrolled asthma of any classification

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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