[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06517017":3,"trial-entities:NCT06517017":112,"trial-summary:NCT06517017":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":39,"secondary_outcomes":44,"sex":65,"minimum_age":66,"maximum_age":17,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":84,"locations":87,"central_contacts":103,"overall_officials":105,"references":110,"see_also_links":111},"NCT06517017","HCI171326","Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma","Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma: A Phase 2 Multicenter Study","RECRUITING","2027-11","2025-11","2025-11-28","2025-10-09","University of Utah","OTHER",true,"Historically, the frailest patients with multiple myeloma are under-represented in clinical trials, and have very high rates of treatment discontinuation, and early treatment mortality. The investigators hypothesize that a go-slow gentle approach to starting treatment in such patients, starting with just Isatuximab and dexamethasone with a gentle introduction to lenalidomide third cycle onwards, may improve treatment adherence and quality of life. The goal of this clinical trial is to learn if a go-slow approach to treating MM in ultra-frail patients may improve the ability to adhere to treatment and improve quality of life.",null,[19,20],"Multiple Myeloma","Plasma Cell Leukemia",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},40,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","Isatuximab","Subcutaneous isatuximab will be administered weekly on a 28-day cycle during the first two cycles, and every two weeks of a 28-day cycle thereafter. Dexamethasone will be administered on the days of isatuximab administration and can be discontinued after two cycles of therapy, or continued at discretion of investigator. Lenalidomide, will be added after two cycles of therapy have been completed.",[35],"Combination Treatment",[37,38],"Dexamethasone","Lenalidomide",[40],{"measure":41,"description":42,"timeFrame":43},"Completion rate of 9 cycles of treatment","Assess the feasibility of approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of lenalidomide from the third cycle onwards in ultra-frail patients with myeloma","At the end of 9 cycles of treatment (each cycle is 28 days)",[45,49,53,55,57,59,61],{"measure":46,"description":47,"timeFrame":48},"Change in quality of life as per the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 domain","Assess if an approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of a lenalidomide in ultra-frail patients with myeloma leads to an improvement in quality of life as measured by the EORTC score. The questionnaire has 10 subscales, each with a score range of 0 to 100 points. Higher scores on the functional scales and global quality of life indicate better functioning, while higher scores on the symptom scales indicate a higher symptom burden. The QLQ-C30 summary score is calculated by averaging the scores of the 13 scales and items, with a higher score indicating a better health-related quality of life (HRQoL).","At the end of 4 cycles of treatment (each cycle is 28 days)",{"measure":50,"description":51,"timeFrame":52},"Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type","Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population.","At study completion. Participants will be enrolled in study for about 3 years.",{"measure":54,"description":51,"timeFrame":52},"Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0)",{"measure":56,"description":51,"timeFrame":52},"Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness",{"measure":58,"description":51,"timeFrame":52},"Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration",{"measure":60,"description":51,"timeFrame":52},"Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment",{"measure":62,"description":63,"timeFrame":64},"Overall survival (OS)","Assess overall survival in this study population","Time from registration until 3 years from start of therapy or death from any cause.","ALL","18 Years",false,{"inclusion":69,"exclusion":78,"raw_text":83},[70,71,72,73,74,75,76,77],"Male or female subject aged ≥ 18 years.","Histologically confirmed myeloma and\u002For Plasma Cell Leukemia who are newly diagnosed and having completed ≤ 1 prior cycle of myeloma treatment.","For female subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization (bilateral oophorectomy or hysterectomy). The post-menopausal status will be defined as having been amenorrheic for 24 months without an alternative medical cause.","Subjects must be willing to follow contraception requirements listed in the protocol, agree to participate in the Lenalidomide REMS program, and have signed the Patient-Physician Agreement Form.","Male subjects must agree to use a latex condom during intercourse for the duration of study therapy as described in the protocol, even if he has undergone a successful vasectomy.","Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy per the treating investigator.","Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.","IMWG defined frailty score ≥ 3. IMWG definition available here: http:\u002F\u002Fwww.myelomafrailtyscorecalculator.net",[79,80,81,82],"Receiving other investigational agents.","Any condition that would, in the Investigator's judgment, compromise the subject's ability to understand the subject information, give informed consent, and\u002For contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)","Known prior severe hypersensitivity (NCI CTCAE v5.0 Grade ≥ 3) to investigational product (IP) or any component in its formulations. This includes hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.","Subjects currently taking prohibited medications as described in the protocol.","Inclusion Criteria:\n\n* Male or female subject aged ≥ 18 years.\n* Histologically confirmed myeloma and\u002For Plasma Cell Leukemia who are newly diagnosed and having completed ≤ 1 prior cycle of myeloma treatment.\n* For female subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization (bilateral oophorectomy or hysterectomy). The post-menopausal status will be defined as having been amenorrheic for 24 months without an alternative medical cause.\n* Subjects must be willing to follow contraception requirements listed in the protocol, agree to participate in the Lenalidomide REMS program, and have signed the Patient-Physician Agreement Form.\n* Male subjects must agree to use a latex condom during intercourse for the duration of study therapy as described in the protocol, even if he has undergone a successful vasectomy.\n* Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy per the treating investigator.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* IMWG defined frailty score ≥ 3. IMWG definition available here: http:\u002F\u002Fwww.myelomafrailtyscorecalculator.net\n\nExclusion Criteria:\n\n* Receiving other investigational agents.\n* Any condition that would, in the Investigator's judgment, compromise the subject's ability to understand the subject information, give informed consent, and\u002For contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n* Known prior severe hypersensitivity (NCI CTCAE v5.0 Grade ≥ 3) to investigational product (IP) or any component in its formulations. This includes hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.\n* Subjects currently taking prohibited medications as described in the protocol.",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":89,"status":8,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":100},"Huntsman Cancer Institute at the University of Utah","Salt Lake City","Utah","84112","United States",[95],{"name":96,"role":97,"phone":98,"email":99},"Rachel Kingsford","CONTACT","801-585-0115","rachel.kingsford@hci.utah.edu",{"lat":101,"lon":102},40.76078,-111.89105,[104],{"name":96,"role":97,"phone":98,"email":99},[106],{"name":107,"affiliation":108,"role":109},"Ghulam Rehman Mohyuddin, MBBS","Huntsman Cancer Institute","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":113,"biomarkers":114},[19,20],[],{"nct_id":4,"found":15,"summary":116,"prompt_version":126},{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This interventional study plans to enroll 40 participants. It is not specified if it is randomized or blinded.","completed","Isatuximab, Dexamethasone, and Lenalidomide for Ultra-Frail Multiple Myeloma","This study is looking at a new way to treat multiple myeloma (a cancer of plasma cells in the bone marrow) in patients who are very frail. It uses a \"go-slow\" approach with three medications: Isatuximab, Dexamethasone, and Lenalidomide. The study starts with Isatuximab and Dexamethasone, then slowly adds Lenalidomide in the third cycle. The goal is to see if this gentle approach helps patients stick with their treatment and improves their quality of life. You may be able to join if you are 18 or older, have newly diagnosed multiple myeloma or plasma cell leukemia, and have had no more than one previous treatment cycle. The study will measure how many patients complete 9 cycles of treatment.","The primary endpoint is measured at the end of 9 cycles of treatment, with each cycle lasting 28 days.",118,"You would receive Isatuximab weekly for the first two cycles, then every two weeks. Dexamethasone is given on the same days as Isatuximab and may be stopped after two cycles or continued. Lenalidomide is introduced from the third cycle onwards.","Not stated in the trial record.",[32],"v2"]