{"commentary":{"count":11,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":11},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01169337\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NCT01169337","nct_id":"NCT01169337","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct01169337. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","label":"Arm A (lenalidomide)","type":"EXPERIMENTAL"},{"description":"Patients undergo observation until progression to symptomatic myeloma.","label":"Arm B (observation)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-05-19","type":"ESTIMATED"},"conditions":["Light Chain Deposition Disease","Smoldering Multiple Myeloma"],"enrollment":{"count":226,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Clinical Observation","type":"OTHER"},{"name":"Lenalidomide","type":"DRUG"},{"name":"Quality-of-Life Assessment","type":"OTHER"}],"last_update":"2026-10-01","lead_sponsor":"National Cancer Institute (NCI)","official_title":"Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2019-01-25","type":"ACTUAL"},"primary_outcomes":[{"measure":"Proportion of Patients With Grade 3 Adverse Events That Effect Vital Organ Function or Any Grade 4 or Higher Non-hematologic Adverse Events (Phase II Primary Endpoint)","timeFrame":"Assessed every 4 weeks while on treatment up to 24 weeks"},{"measure":"2-year Progression-free Survival (PFS) Rate (Phase III Primary Endpoint)","timeFrame":"Assessed every 3 months for 2 years"}],"references":[{"citation":"Lonial S, Jacobus S, Fonseca R, Weiss M, Kumar S, Orlowski RZ, Kaufman JL, Yacoub AM, Buadi FK, O'Brien T, Matous JV, Anderson DM, Emmons RV, Mahindra A, Wagner LI, Dhodapkar MV, Rajkumar SV. Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma. J Clin Oncol. 2020 Apr 10;38(11):1126-1137. doi: 10.1200/JCO.19.01740. Epub 2019 Oct 25.","pmid":"31652094","type":"DERIVED"}],"start_date":{"date":"2011-01-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT01169337"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct01169337"}