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A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."

A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04998786
Acronym
I2D IFM2021_03
Enrollment
75
Registered
2021-08-10
Start date
2021-12-14
Completion date
2030-01-01
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma at First Relapse

Keywords

Multiple Myeloma, elderly patients, first relapse, previous exposed, High Risk, Ixazomib, Iberdomide, Dexametasone

Brief summary

This is a phase II, multicenter, open-label study to evaluate the rate of patients achieving very good partial response (VGPR) or better to the oral combination Iberdomide Ixazomib Dexamethasone in elderly patients with multiple myeloma at first relapse . The patient population will consist of adult men and women more than 70 years, who meet eligibility criteria. Following the screening period, patients will be enrolled and treated then, they will receive therapy with Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression.

Interventions

DRUGIxazomib

Ixazomib 3 mg/day (days 1, 8, 15) cycle 1 to until progress

DRUGIberdomide

Iberdomide 1.6 mg / day (day 1 to 21) cycle 1 to until progress

DRUGDexamethasone Oral

Cycle 1 and 2 Dexaméthasone 20 mg/day on days 1, 8, 15, 22 Cycle 3 to 6 Dexamethasone 10 mg/day on days 1, 8, 15, 22

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age \> 70 years 2. Eastern Collaborative Oncology Group (ECOG) performance score of ≤2 3. Life expectancy \> 6 months 4. Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care. 5. Symptomatic multiple myeloma (MM) at first relapse, as defined below: * Symptomatic multiple myeloma according to international criteria.(Rajkumar et al, 2014) * Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy. 6. Subject must have received one prior line of therapy for at least 3 cycles. 7. Subject has measurable disease at Screening, defined at least one of the following: * Serum M-protein ≥ 0.5 gram (g)/deciliter (dL), OR * Urine M-protein ≥ 200 mg in 24 hours, OR * Serum immunoglobulin free light chain (FLC) ≥ 10 mg/dL provided serum FLC ratio is abnormal. 8. Subjects must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1): * Absolute neutrophil count (ANC) ≥ 1000/microliter (μL). Subjects may use growth factor support to achieve ANC eligibility criteria. * Platelet count ≥ 75,000 /mm3 for subjects in whom \< 50% of bone marrow nucleated cells are plasma cells; or a platelet count ≥ 50,000/mm3 for subjects in whom \> 50% of bone marrow nucleated cells are plasma cells. It is not permissible to transfuse subjects to achieve minimum platelet counts within 3 days before study. --AST and ALT ≤ 3 × upper limit of normal (ULN). * Total bilirubin ≤ 1.5 × ULN. Subjects with documented Gilbert's syndrome may have bilirubin \> 1.5 × ULN with the approval of the Primary Therapeutic Area Medical Director * Creatinine clearance (CrCl) ≥ 30 milliliter (mL)/minute (min) (using Cockroft and Gault Formula) 9. Patient should comply with Celgene's pregnancy prevention plan for Iberdomide (please see appendix 8 Iberdomide Pregnancy Prevention Plan for subjects in clinical trials) 10. Female patients who: * are postmenopausal for at least 24 months before the screnning visit, OR * are surgically sterile (have undergone a hysterectomy or bilateral oophorectomy) 11. Men even if surgically sterilized must agree to not father a child and agree to practice complete abstinence or to use a condom during therapy and dose interruptions and for 90 days after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential or pregnant. Non-inclusion Criteria: 1. Subject is refractory to bortezomib, defined as progression on or within 60 days of the last dose of bortezomib. 2. Subject has had prior treatment with ixazomib, carfilzomib, pomalidomide or iberdomide 3. Subject has any of the following conditions: * Non-secretory or oligo-secretory MM * Light chain Amyloidosis (AL Amyloidosis) * POEMS syndrome Waldenström macroglobulinemia 4. Known Human Immunodeficiency Viral (HIV) infection 5. Active hepatitis B or C infection based on blood screen tests 6. Significant cardiovascular or pericardial disease, including uncontrolled angina, hypertension, arrhythmia, recent myocardial infarction within 6 months, congestive, heart failure New York Heart Association (NYHA) Class ≥ 3 7. Major surgery within 4 weeks prior screening 8. Acute infections requiring parenteral therapy (antibiotic, antifungal or antiviral) within 14 days 9. ≥ Grade 3 Peripheral neuropathy or grade 2 with pain 10. Uncontrolled diabetes or uncontrolled hypertension within 14 days 11. Any other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study 12. Subject has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with the following exceptions: * Adequately treated in situ carcinoma of the cervix uteri or the breast, * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, * Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment, * Previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study. 13. Known intolerance to steroid therapy 14. Serious medical or psychiatric illness likely to interfere with participation in study 15. Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs 16. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment 17. Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients have very good partial response (VGPR) or betterapproximate 18 monthsUsing IMWG criteria

Secondary

MeasureTime frameDescription
Number of adverse eventsapproximate 18 monthsNumber of adverse events defined by Common Terminology Criteria for Adverse Events (v5)
Number of responses3 monthsPartial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and minor response (MR) will be evaluated according to IMWG
Number of the deathapproximate 18 monthsis defined as the time in months from inclusion to the date of death due to any cause. Subject alive will be censored at the last known alive date.
Number of progressionapproximate 18 monthsis defined as the time in months from inclusion to the date of disease progression or death due to any cause, using IMWG criteria
Percentage of time to progressionapproximative 18 monthsis defined as the time in months from inclusion to the date of disease progression or death due to any cause, using IMWG criteria
Percentage of duration of responseapproximative 18 monthsis defined as the time from the first response (PR or better) to the date of disease progression or death due to any cause
Percentage of duration of therapyapproximative 18 monthsis defined as the time from treatment initiation to the last dose of therapy
Percentage of time to responseapproximative 18 monthsaccording IMWG
Percentage of Overall Response Rateapproximative 18 monthsaccording IMWG
Percentage of value of biological prognostic factorsday 1prognostic factors as ISS stage, cytogenetic as del(17p), t(4;14),
Percentage of frailty scoresday 1age, ECOG, comorbidity index
Percentage of score of quality of lifeapproximative 18 monthsTo assess Quality of Life EQ5D and SF36

Countries

France

Contacts

PRINCIPAL_INVESTIGATORCyrille Touzeau

Nantes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026