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

NCT05392946 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: MC20080721-006604
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) of iberdomide (Phase I)

  MTD is defined as the highest tested dose level that is determined to have acceptable toxicity and tolerability based on dose limiting toxicity definitions.

  Up to 12 cycles. Each cycle is 28 days.

• Complete response rate (Phase II)

  A confirmed complete response is defined as a patient who has achieved an stringent complete response (sCR) or complete response (CR) and maintained it on two consecutive evaluations at any time during induction therapy. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

  Up to 3 years

Secondary Outcomes (6)

• Overall response rate (Phase II)

  Up to 3 years

• VGPR or better response rate (Phase II)

  Up to 3 years

• Progression-free survival (Phase II)

  Up to 3 years

• Overall survival (Phase II)

  Up to 3 years

• Incidence of adverse events (AEs) (Phase II)

  Up to 30 days after discontinuation

Other Outcomes (2)

• Minimal residual disease

  Up to 3 years

• Proportion of patients who achieve sustained MRD negative status

  At the end of cycles 24 and 36. Each cycle is 28 days.

Study Arms (1)

Treatment (iberdomide, bortezomib, dexamethasone, daratumumab)

EXPERIMENTAL

INDUCTION PHASE: Patients receive iberdomide PO QD on days 1-21, bortezomib SC on days, 1, 8, 15, and 22, and dexamethasone PO on days 1, 8, 15, 22. Patients also receive daratumumab SC on days 1, 8, 15, 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 13-36 CYCLES: Patients receive iberdomide PO QD on days 1-21. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.

Drug: Bortezomib; Biological: Daratumumab; Drug: Dexamethasone; Drug: Iberdomide

Interventions

Bortezomib DRUG

Given SC

Also known as: [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341, PS341, Velcade

Treatment (iberdomide, bortezomib, dexamethasone, daratumumab)

Daratumumab BIOLOGICAL

Given SC

Also known as: Darzalex, HuMax-CD38, JNJ-54767414, Daratumumab Biosimilar HLX15, Daratumumab-fihj

Treatment (iberdomide, bortezomib, dexamethasone, daratumumab)

Dexamethasone DRUG

Given PO

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Treatment (iberdomide, bortezomib, dexamethasone, daratumumab)

Iberdomide DRUG

Given PO

Also known as: CC 220, CC-220

Treatment (iberdomide, bortezomib, dexamethasone, daratumumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; daratumumab; Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; iberdomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Prashant Kapoor, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 26, 2022
• Study Start: August 11, 2022
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): September 29, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)