[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"smoldering-plasma-cell-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:smoldering-plasma-cell-myeloma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,64,86,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100357713","phase-3-lenalidomide-and-dexamethasone-with-or-without-daratumumab-in-treating-patients-with-high-risk-smoldering-myeloma-100357713",false,"NCT03937635","Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma","Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)","Inclusion Criteria:\n\n* Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months. High-risk is defined by the presence of 2 or more of the following factors:\n\n  * Abnormal serum free light chain ratio of involved to uninvolved \\>20, but less than 100 if the involved FLC is \\>= 10 mg\u002FdL by serum free light chain (FLC) assay\n  * Serum M-protein level \\>= 2 gm\u002FdL\n  * Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies.\n  * \\>20% plasma cells on biopsy or aspirate\n* Bone marrow aspirate and\u002For biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.\n* \\>= 1 g\u002FdL on serum protein electrophoresis (within 28 days prior to randomization).\n* \\>= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis (within 28 days prior to randomization).\n\n  * NOTE: In the rare situation where the serum protein electrophoresis (SPEP) is felt to be unreliable, then quantitative immunoglobulin levels on nephelometry or turbidometry can be accepted.\n* SPEP, urine protein electrophoresis (UPEP), and serum FLC are required to be performed within 28 days prior to randomization.\n\n  * NOTE: UPEP (on a 24-hour collection) is required; no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is \\>= 200 mg\u002F24 hour (hr), and urine in addition to serum must be followed in order to confirm a very good partial response (VGPR) or higher response.\n* Patients must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., \\> 11 mg\u002FdL or 1mg\u002FdL above upper limit of normal \\[ULN\\]).\n* Hemoglobin \\>= 11 g\u002FdL (within 28 days prior to randomization).\n* Platelet count \\>= 100,000 cells\u002Fmm\\^3 (within 28 days prior to randomization).\n* Absolute neutrophil count \\>= 1500 cells\u002Fmm\\^3 (within 28 days prior to randomization).\n* Calculated creatinine clearance \\>= 30 mL\u002Fmin (within 28 days prior to randomization).\n* Bilirubin =\\\u003C 1.5 mg\u002FdL (within 28 days prior to randomization).\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) =\\\u003C 2.5 times the upper limit of normal (within 28 days prior to randomization).\n* Patients must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patients must also not have contraindication to deep vein thrombosis (DVT) prophylaxis\u002Faspirin.\n* Patients must not have more than one focal marrow lesion on magnetic resonance imaging (MRI) of either pelvis or spine. Patients with indwelling pacemakers and\u002For ICD (implantable cardioverter-defibrillator) that is known or suspected to be MRI incompatible will be excused from this test.\n* Concurrent use of erythropoietin is not allowed while on study therapy.\n* Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted. Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day. Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.\n* Patients must not have active, uncontrolled seizure disorder. Patients must not have had a seizure in the last 6 months.\n* Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome.\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.\n* Patients with monoclonal gammopathy of undetermined significance are not eligible.\n* Patients must not have grade 2 or higher peripheral neuropathy per CTCAE.\n* Patients must not have active, uncontrolled infection.\n* Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.\n* Patients should not have New York Heart Association classification III or IV heart failure at baseline.\n* Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer. For most diseases this time frame is 5 years.\n* Patients must agree to register into the mandatory Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of REMS.\n* Women must not be pregnant due to potential harm to the fetus from daratumumab and lenalidomide. All females of childbearing potential (FCBP) must have a blood test or urine study with a sensitivity of at least 25 mIU\u002FmL within 10-14 days prior to the first dose of lenalidomide and again within 24 hours prior to the first dose of lenalidomide. FCBP must also agree to ongoing pregnancy testing while on treatment. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 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).\n* Females of childbearing potential (FCBP) must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting study treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 28 days after the last dose of protocol treatment (FCBP who are assigned to Arm A and receive daratumumab must extend this contraception requirement to 3 months after the last dose of protocol treatment). Women must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a FCBP while participating in the study and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment.\n* Human immunodeficiency virus (HIV)+ patients with undetectable HIV viral loads tested within 6 months are eligible.\n* Patients should not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to daratumumab, lenalidomide, or dexamethasone.\n* Patients must not have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal or known moderate or severe persistent asthma within 2 years prior to randomization","ALL","18 Years",{"count":19,"type":20},288,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.",[26],"Smoldering Plasma Cell Myeloma","RECRUITING","2026-06-16",{"date":30,"type":31},"2026-06-18","ACTUAL",{"date":33,"type":31},"2019-09-16",{"date":35,"type":20},"2029-12-31",{"name":37,"class":38},"ECOG-ACRIN Cancer Research Group","NETWORK",747,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100422097","phase-2-iberdomide-alone-or-in-combination-with-dexamethasone-for-the-treatment-of-intermediate--or-high-risk-smoldering-multiple-myeloma-100422097","NCT04776395","Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma","Iberdomide in Intermediate- and High-Risk Smoldering Myeloma (SMM) Patients: A Phase 2 Study With a Safety Run-in","Inclusion Criteria:\n\n* Subject must have intermediate- or high risk smoldering multiple myeloma (SMM) as confirmed by at least one of the following factors either at screening or within 28 days of screening:\n\n  * Bone marrow clonal plasma cells \\>= 20% confirmed on either screening bone marrow biopsy or by outside pathology ≤5 years from initiation of study drug.\n  * Abnormal serum free light chain ratio \\> 20 by serum free light chain (FLC) assay\n  * Serum monoclonal protein \\>= 2 g\u002FdL\n* Subject must have been diagnosed with SMM =\\\u003C 5 years from initiation of study drug\n* Both men and women of all races and ethnic groups are eligible for this study\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky \\>= 60%) is required for eligibility\n* Absolute neutrophil count (ANC) \\>= 1500\u002FuL\n* Hemoglobin (Hgb) \\> 11 g\u002FdL\n* Platelet count \\>= 100,000 cells\u002Fmm\\^3 and must be platelet and packed red blood cells (PRBC) transfusion independent with no granulocyte colony-stimulating factor (G-CSF) to ensure eligibility within 8 weeks of screening\n* Estimated creatinine clearance \\>= 30 mL\u002Fmin as defined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or Cockcroft-Gault\n* Total bilirubin \\\u003C 2 mg\u002FdL except in subjects with congenital bilirubinemia such as Gilbert syndrome, in which case direct bilirubin =\\\u003C 2 times the institutional upper limit of normal is required\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5 times the institutional upper limit of normal\n* Left ventricular ejection fraction \\>= 40%\n* Females of childbearing potential (FCBP) must have two negative pregnancy tests as verified by the investigator prior to starting study treatment. The effects of Iberdomide on the developing human fetus are unknown. For this reason, women of child-bearing potential 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. A FCBP must 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 (including dose interruptions), and for at least 28 days after the last dose of iberdomide. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Female of childbearing potential (FCBP) is a sexually mature woman who:\n\n  * Has not undergone a hysterectomy or bilateral oophorectomy; or\n  * Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* The subject must be willing to comply with fertility requirements as below:\n\n  * Male subjects must agree to use an adequate method of contraception for the duration of the study and for 3 months afterwards\n  * Female subjects must be either postmenopausal, free from menses \\>= 2 years (yrs), surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from heterosexual activity starting with screening and for 3 months after last treatment in all patients\n  * Patients must agree not to donate blood, sperm\u002Fova while taking protocol therapy and for at least 4 weeks after stopping treatment\n* Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments\u002Fprocedures being conducted\n* Subject is willing and able to adhere to the study visit schedule and other protocol requirements\n* Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n\nExclusion Criteria:\n\n* Multiple myeloma requiring treatment as defined by SLiM-CRAB criteria\n* Monoclonal gammopathy of undetermined significance (MGUS), polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS syndrome), plasma cell leukemia, primary systemic light chain (AL) amyloidosis, or Waldenstroms macroglobulinemia\n* Concurrent intravenous bisphosphonate use more often than once a year\n* Prior or ongoing treatment for plasma cell disorder\n* Active hepatitis B or C due to risk of infection made worse by study drug\n* If subject has human immunodeficiency virus (HIV), they must have a CD4 count \\>= 350, no history of acquired immune deficiency syndrome-related illness, and not currently prescribed zidovudine or stavudine\n* Subjects may be receiving concomitant low dose corticosteroids (e.g., prednisone up to but no more than 10 mg by mouth daily or its equivalent) for symptom management and comorbid conditions\n* Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV), unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the preceding 6 months, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Subjects with gastrointestinal disease that may significantly alter the absorption of iberdomide\n* Pregnant women are excluded from this study because protocol therapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to protocol treatment of the mother, breastfeeding should be discontinued\n* Current or prior use of immunosuppressive medication within 14 days prior to the first dose of iberdomide. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection); systemic corticosteroids at physiologic doses that do not exceed 10 mg\u002Fday of prednisone or equivalent steroids as premedication for hypersensitivity reactions (e.g, computed tomography \\[CT\\] scan pre-medications)",{"count":48,"type":20},68,[50],"PHASE2","This phase II trial studies the effects of iberdomide when given alone or in combination with dexamethasone in treating intermediate or high-risk smoldering multiple myeloma patients. Immunotherapy with iberdomide may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Dexamethasone is a synthetic steroid (similar to steroid hormones produced naturally in the adrenal gland), and is used with other drugs in the treatment of some types of cancer. Giving iberdomide with dexamethasone my improve time to progression to symptomatic myeloma with improved tolerability.",[26],"2026-05-28",{"date":55,"type":31},"2026-06-01",{"date":57,"type":31},"2021-07-09",{"date":59,"type":20},"2029-09-01",{"name":61,"class":62},"Emory University","OTHER",1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":63},"100264823","observational-prospective-research-study-in-monoclonal-gammopathies-leading-to-myeloma-100264823","NCT02726750","Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma","Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma (ORIGIN Study)","Inclusion Criteria:\n\n* Patients with monoclonal gammopathy of unknown significance. Both criteria must be met:\n\n  * Serum monoclonal protein \\\u003C 3 g\u002FdL or urinary monoclonal protein \\\u003C 500 mg per 24 hours and clonal bone marrow plasma cells \\\u003C 10%\n  * Absence of myeloma defining events or amyloidosis\n* Patients with smoldering multiple myeloma. Both criteria must be met:\n\n  * Serum monoclonal protein \\>= 3 g\u002FdL or urinary monoclonal protein \\>= 500 mg per 24 hours and\u002For clonal bone marrow plasma cells 10-60%\n  * Absence of myeloma defining events or amyloidosis\n\nExclusion Criteria:\n\n* Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least one of the following\n\n  * Hypercalcemia: serum calcium \\> 0.25 mmol\u002FL (\\> 1 mg\u002FdL) higher than the upper limit of normal or \\> 2.75 mmol\u002FL (\\> 11 mg\u002FdL)\n  * Renal Insufficiency: creatinine clearance \\\u003C 40 ml\u002Fmin or serum creatinine \\> 2 mg\u002FdL\n  * Anemia: hemoglobin value \\\u003C 10 g\u002FdL or 2 g\u002FdL \\\u003C normal reference\n  * Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2\\[F-18\\] fluoro-D-glucose positron emission tomography CT (PET-CT)\n  * Clonal bone marrow plasma cell percentage \\>= 60%\n  * Involved:uninvolved serum free light chain ratio \\>= 100 measured by Freelite assay (The Binding Site Group, Birmingham, United Kingdom \\[UK\\])\n  * \\> 1 focal lesions on magnetic resonance imaging (MRI) studies (each focal lesion must be 5 mm or more in size)\n* Prior or concurrent systemic treatment for asymptomatic monoclonal gammopathies\n\n  * Bisphosphonates are permitted\n  * Radiotherapy is not permitted\n  * Prior treatment with chemotherapy or investigational agents for asymptomatic gammopathies is not permitted\n* Plasma cell leukemia\n* Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness\u002Fsocial situations that would compromise compliance with study requirements",{"count":72,"type":20},200,"OBSERVATIONAL","The goal of this study is to find markers that may help to predict why some patients who have monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma (SMM) that have no signs or symptoms of disease (asymptomatic) develop multiple myeloma, while others do not. Studying markers such as age, level of proteins in blood, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood cells, and bone abnormalities may help researchers to validate clinical and genomic predictors for future use in clinical practice.",[76,26],"Monoclonal Gammopathy of Undetermined Significance","2026-04-20",{"date":79,"type":31},"2026-04-21",{"date":81,"type":31},"2015-12-14",{"date":83,"type":20},"2028-04-30",{"name":85,"class":62},"M.D. Anderson Cancer Center",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":63},"100449770","quality-of-life-in-patients-with-asymptomatic-monoclonal-gammopathies-100449770","NCT05136807","Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies","Inclusion Criteria:\n\n* Patients with either monoclonal gammopathy of unknown significance age \\>= 18 years old.\n\n  * Both criteria must be met:\n\n    * Serum monoclonal protein \\\u003C 3 g\u002FdL or urinary monoclonal protein \\\u003C 500 mg per 24 hours and clonal bone marrow plasma cells \\\u003C 10%\n    * Absence of myeloma defining events or amyloidosis\n* OR Patients with smoldering multiple myeloma age \\>= 18 years old.\n\n  * Both criteria must be met:\n\n    * Serum monoclonal protein \\>= 3 g\u002FdL or urinary monoclonal protein \\>= 500 mg per 24 hours and\u002For clonal bone marrow plasma cells 10-60%\n    * Absence of myeloma defining events or amyloidosis\n* Patients must be enrolled in clinical trials for SMM or MGUS at MD Anderson Cancer Center, including protocols PA15-0575 (NCT02726750) (Prospective observational study of clinical and genomic predictors of progression to myeloma in asymptomatic monoclonal gammopathies); 2015-0148 (Phase II single arm trial of Isatuximab in patients with intermediate and high risk smoldering multiple myeloma); and 2015-0371 (NCT02603887) (Pilot single arm, single center, open label trial of Pembrolizumab in patients with intermediate and high risk smoldering multiple myeloma) and any future clinical trials for MGUS and\u002For SMM that open at MD Anderson Cancer Center.\n* Only patients who are English or Spanish speaking are eligible.\n\nExclusion Criteria:\n\n* Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least one of the following\n\n  * Hypercalcemia: serum calcium \\> 0.25 mmol\u002FL (\\> 1 mg\u002FdL) higher than the upper limit of normal or \\> 2.75 mmol\u002FL (\\> 11 mg\u002FdL)\n  * Renal Insufficiency: creatinine clearance \\\u003C 40 ml\u002Fmin or serum creatinine \\> 2 mg\u002FdL\n  * Anemia: hemoglobin value \\\u003C 10 g\u002FdL or 2 g\u002FdL \\\u003C normal reference\n  * Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2\\[F-18\\] fluoro-D-glucose positron emission tomography CT (PET-CT).\n  * Clonal bone marrow plasma cell percentage \\>= 60%\n  * Involved: uninvolved serum free light chain ratio \\>= 100 measured by Freelite assay (The Binding Site Group, Birmingham, United Kingdom \\[UK\\])\n  * \\>1 focal lesions on magnetic resonance imaging (MRI) studies, if the patient has an MRI done per eligibility criteria (each focal lesion must be 5 mm or more in size)\n* Plasma cell leukemia.\n* Presence of cognitive impairment or delirium as determined by the primary clinician.",{"count":93,"type":20},400,"This study examines the quality of life in patients with monoclonal gammopathy of unknown significance and smoldering multiple myeloma. Collecting quality of life information from patients may help doctors learn more about the most common symptoms and concerns patients with monoclonal gammopathy of unknown significance and smoldering multiple myeloma may have.",[76,26],"2026-04-10",{"date":98,"type":31},"2026-04-15",{"date":100,"type":31},"2016-06-07",{"date":102,"type":20},"2027-02-02",{"name":85,"class":62},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":63},"100463250","non-chemotherapeutic-interventions-for-the-improvement-of-quality-of-life-and-immune-function-in-patients-with-multiple-myeloma-100463250","NCT05312255","Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma","Improving Host Factors in Patients With Monoclonal Gammopathies and Other Hematologic Disorders","Inclusion Criteria:\n\n* Age \\>= 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of:\n\n  * Module A: ECOG 0 - 1\n  * Module B: ECOG 0 - 2\n  * Module C: ECOG 0 - 2\n  * Module D: ECOG 0-1\n* MODULE A, B and C: Have a diagnosis of smoldering multiple myeloma, multiple myeloma or plasma cell leukemia (PCL) or\n* MODULE D: non transfusion dependent low-risk MDS\n* Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion\n* Are able to understand and follow assessment and intervention procedures\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n* MODULE A and D (PHYSICAL ACTIVITY): Participant has access to a personal computer or tablet with camera, microphone, speakers and internet access\n* MODULE B (NUTRITION): Not applicable\n* MODULE C (BETA BLOCKER): Newly diagnosed patients with multiple myeloma necessitating treatment and before initiation of systemic therapy\n* MODULE C: Female participants of child-bearing potential must have a negative pregnancy test at study entry and then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Male patients with female partners of child-bearing potential should also use adequate contraceptive methods (see above). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately MODULE D: Patients with MDS not necessitating transfusion therapy at time of enrollment (no transfusion within 8 weeks prior to enrollment) i.e. patients on observation, or receiving growth factors or luspatercept only\n\nExclusion Criteria:\n\n* Major comorbidities that would cause danger to the patient when participating in the study and that would have a risk of progression if the patient took part in the study (including, but not limited to): cardiac or pulmonary and infectious diseases (e.g., ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) or, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention (comorbidities, myeloma symptoms, treatment side effects)\n* MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system that is deemed to making the patient unsafe to participate. This will be assessed by radiologist, a neurosurgeon and\u002For an orthopedic surgeon, if applicable.\n* MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system\n* MODULE A (PHYSICAL ACTIVITY): Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced surgeon\n* MODULE B (NUTRITION): Clinical signs of malnutrition (body mass index \\[BMI\\] \\\u003C 18)\n* MODULE B (NUTRITION): Special diets (physician prescribed)\n* MODULE B (NUTRITION): Diabetic treated with glucose-lowering medications and\u002For insulin\n* MODULE B (NUTRITION): Other reasons not to withhold food\n* MODULE B (NUTRITION): Any condition which in the investigator's opinion deems the participant an unsuitable candidate to limit food consumption\n* MODULE C (BETA BLOCKER): Current use of a beta blocker (includes all non-selective and beta-1 selective blockers) or, use of a beta-blocker within 3 months of study enrollment\n* MODULE C (BETA BLOCKER): Contraindications to the use of beta-blockers, e.g.; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree, uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association \\[NYHA\\] Grade III or IV), hypotension ( systolic blood pressure \\\u003C 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), uncontrolled type I or type II diabetes mellitus (HbA1C \\> 8.5 or 12h fasting plasma glucose \\> 160 mg\u002FdL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded\n* MODULE C (BETA BLOCKER): Pregnant or nursing female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test\n* MODULE D: Cardiovascular disease which is deemed limiting exercise readiness by a cardiologist",{"count":112,"type":20},175,[114],"NA","This clinical trial investigates the effect of non-chemotherapeutic interventions in patients with multiple myeloma or MDS. Non-chemotherapeutic interventions such as physical activity and nutritional interventions (e.g., modifications in diet) have been shown to positively affect the immune system and improve overall quality of life. Another purpose of this study is for researchers to learn how the addition of a beta-blocker (propranolol) to the standard treatment regimen in patients with newly diagnosed multiple myeloma affects immune response and quality of life. A study from the Mayo Clinic looked at multiple myeloma patients who were on a beta-blocker while undergoing chemotherapy and found that the use of a beta-blocker resulted in improved patient survival outcomes. Non-chemotherapeutic treatment options may help decrease symptoms and improve quality of life for patients with multiple myeloma.",[117,118,119,26],"Plasma Cell Myeloma","Recurrent Plasma Cell Myeloma","Refractory Plasma Cell Myeloma","2025-11-28",{"date":122,"type":31},"2025-12-01",{"date":124,"type":31},"2022-06-28",{"date":126,"type":20},"2027-06-28",{"name":128,"class":62},"Roswell Park Cancer Institute"]