Dexamethasone sodium phosphate for Multiple myeloma|Relapsed multiple myeloma (first relapse)

Inclusion criteria

• {"criterion_text":"- 1.\tAge >/= 70 years\n- 10.\tFemale patients who: - are postmenopausal for at least 24 months before the screnning visit, OR - are surgically sterile (have undergone a hysterectomy or bilateral oophorectomy)\n- 11.\tMen 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.\n- 2.\tEastern Collaborative Oncology Group (ECOG) performance score of ≤ 2\n- 3.\tLife expectancy > 6 months\n- 4.\tVoluntary 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.\n- 5.\tSymptomatic 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.\n- 6.\tSubject must have received one prior line of therapy for at least 3 cycles.\n- 7.\tSubject 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.\n- 8.\tSubjects must meet the following laboratory parameters, per laboratory reference range (performed no more than 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 MDRD method)\n- 9.\tPatient should comply with Celgene’s pregnancy prevention plan for Iberdomide (please see appendix 8 Iberdomide Pregnancy Prevention Plan for subjects in clinical trials)"}

Exclusion criteria

• {"criterion_text":"- 1)\tSubject is refractory to bortezomib, defined as progression on or within 60 days of the last dose of bortezomib.\n- 10)\tUncontrolled diabetes or uncontrolled hypertension within 14 days\n- 11)\tAny other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study\n- 12)\tSubject 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.\n- 13)\tKnown intolerance to steroid therapy\n- 14)\tSerious medical, cognitive or psychiatric illness likely to interfere with participation in study\n- 15)\tIncidence of gastrointestinal disease that may significantly alter the absorption of oral drugs\n- 16)\tSubjects unable or unwilling to undergo antithrombotic prophylactic treatment\n- 17)\tPerson under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision\n- 18)\tKnown intolerance to steroid therapy\n- 19)\tHistory of hypersensitivity to any of the study medications, their analogues, or excipients in the various formulations, or to study-required co medication\n- 2)\tSubject has had prior treatment with ixazomib, carfilzomib, pomalidomide or iberdomide\n- 3)\tSubject has any of the following conditions: - Non-secretory or oligo-secretory MM - Light chain Amyloidosis (AL Amyloidosis) - POEMS syndrome - Waldenström macroglobulinemia\n- 4)\tKnown Human Immunodeficiency Viral (HIV) infection\n- 5)\tActive hepatitis B or C infection based on blood screen tests\n- 6)\tSignificant 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\n- 7)\tMajor surgery within 4 weeks prior screening\n- 8)\tAcute infections requiring parenteral therapy (antibiotic, antifungal or antiviral) within 14 days\n- 9)\t≥ Grade 3 Peripheral neuropathy or grade 2 with pain"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the VGPR rate or better (as best response) using IMWG criteria","definition_or_measurement_approach":"Assessed using IMWG criteria to determine rate of patients achieving Very Good Partial Response (VGPR) or better as best response."}

Secondary endpoints

• {"endpoint_text":"- Number of adverse events defined by Common Terminology Criteria for Adverse Events (v5)","definition_or_measurement_approach":""}
• {"endpoint_text":"- ORR including Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and minor response (MR) to Iberdomide Ixazomib and Dexamethasone will be evaluated according to IMWG criteria at 3 months and 6 months of treatment","definition_or_measurement_approach":"Overall response rate (ORR) evaluated according to IMWG criteria at 3 and 6 months of treatment."}
• {"endpoint_text":"- Time to progression (TTP) is defined as the time in months from inclusion to the date of disease progression or death due to any cause. Subject alive or lost to follow-up without experiencing documented disease progression will be censored at the date of last valid disease and response assessment.","definition_or_measurement_approach":"TTP measured in months from inclusion to date of disease progression or death; censoring at last valid disease/response assessment if no progression."}
• {"endpoint_text":"- Time to response (TTR) is defined as the time from inclusion to the date of the first response (PR or better)","definition_or_measurement_approach":"TTR measured from inclusion to date of first documented response (PR or better)."}
• {"endpoint_text":"- Duration of Response (DOR) is defined as the time from the first response (PR or better) to the date of disease progression or death due to any cause. Subject alive or lost to follow-up without experiencing documented disease progression will be censored at the date of last valid disease and response assessment.","definition_or_measurement_approach":"DOR measured from first response (PR or better) to progression or death; censoring at last valid assessment if no progression."}
• {"endpoint_text":"- Duration of therapy (DOT) is defined as the time from treatment initiation to the last dose of therapy","definition_or_measurement_approach":"DOT measured from treatment initiation to last administered dose."}
• {"endpoint_text":"- Fragilty scores (IMWG, IFM Kumar Lancet Oncol 2016) will be assessed at time of inclusion","definition_or_measurement_approach":"Fragility assessed using IMWG and IFM scores at baseline (inclusion)."}
• {"endpoint_text":"- Overall Survival (OS) is 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.","definition_or_measurement_approach":"OS measured in months from inclusion to death; alive subjects censored at last known alive date."}
• {"endpoint_text":"- Value of biological prognostic factors as ISS stage, cytogenetic as del(17p), t(4;14), t(14;16), t(14;20), amp(1q) and del(1p) will be explored. Bone marrow aspirate will be performed at baseline to support translational research project including: plasma cell profiling (cereblon, CD38, CD55, CD59 expression), immunoprofiling (T-cell (CD4, CD8) and NK-cell phenotype)","definition_or_measurement_approach":"Exploratory evaluation of prognostic biologic factors (ISS stage, specified cytogenetics) with baseline bone marrow aspirate for plasma cell and immune profiling (cereblon, CD38, CD55, CD59, T-cell and NK-cell phenotyping)."}
• {"endpoint_text":"- Quality of life (EQ5D and SF36 scales will be used to assess QOL)","definition_or_measurement_approach":"Quality of life assessed using EQ-5D and SF-36 instruments."}

France

Earliest CTIS Part Ii Submission Date

18-10-2024

Latest Decision Or Authorization Date

13-03-2025

Processing Time Days

146

Number Of Sites

22

Number Of Participants

80

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Celgene SAS","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Takeda France SAS","duties_or_roles":"Monetary support","organisation_type":""}