Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020
Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06212323 (Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial), which is not on this map. Cited by 163 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial
Who cites it
163 citing papers in PubMed, 5 syntheses or guidelines pooled it, 298 citations in OpenAlex.
- Efficacy and toxicity of treatment of smoldering multiple myeloma: a systematic review and meta-analysis.Annals of medicine · 2025Pooled it
- Observation or treatment for smoldering multiple myeloma? A systematic review and meta-analysis of randomized controlled studies.Blood cancer journal · 2025Pooled it
- Evaluating early intervention in smoldering myeloma clinical trials: a systematic review.The oncologist · 2025Pooled it
- Patient-Reported Outcomes in Phase 3 Clinical Trials for Blood Cancers: A Systematic Review.JAMA network open · 2024Pooled it
- The effect of intervention versus watchful waiting on disease progression and overall survival in smoldering multiple myeloma: a systematic review of randomized controlled trials.Journal of cancer research and clinical oncology · 2022Pooled it
- Clinical and Psychological Outcomes After Monoclonal Gammopathy Screening: A Population-Based Screening Study and Subsequent Randomized Trial of Follow-Up.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Trial
- Teclistamab versus lenalidomide-dexamethasone in high-risk smoldering multiple myeloma: a randomized phase 2 trial.Nature medicine · 2026Trial
- Daratumumab in high-risk MGUS and low-risk smoldering myeloma: results of the Phase II D-PRISM study.Nature communications · 2026Trial
- Deeper response predicts better outcomes in high-risk-smoldering-myeloma: results of the I-PRISM phase II clinical trial.Nature communications · 2025Trial
- Trial
- The genomic profiling of high-risk smoldering myeloma patients treated with an intensive strategy unveils potential markers of resistance and progression.Blood cancer journal · 2024Trial
- Iceland screens, treats, or prevents multiple myeloma (iStopMM): a population-based screening study for monoclonal gammopathy of undetermined significance and randomized controlled trial of follow-up strategies.Blood cancer journal · 2021Trial
- Race-Dependent Differences in Risk, Genomics, and Epstein-Barr Virus Exposure in Monoclonal Gammopathies: Results of SWOG S0120.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020Trial
- Trial
- A prospective study of familial predisposition to plasma cell dyscrasias.Blood advances · 2026Article
- Dynamic risk stratification in smoldering multiple myeloma: Integrating evolving biomarkers with the 2/20/20 Model.HemaSphere · 2026Article
- Smoldering multiple myeloma: a multi-country mixed-methods study on disease perceptions and patient treatment preferences.Future oncology (London, England) · 2026Article
- Progression-Free Survival Effect Sizes in Randomized Controlled Trials of Targeted Cancer Therapies with Positive Outcomes.Acta haematologica · 2026Article
- Smoldering multiple myeloma: advances in diagnosis and risk stratification, and evolving therapeutic strategies.International journal of hematology · 2026Review
- Multiple Myeloma Screening Education: A Community-Based Health Literacy Intervention.Cancer research communications · 2026Article
103 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
17 authors at 12 institutions in 1 country.
Funding
Abstract
purposeObservation is the current standard of care for smoldering multiple myeloma. We hypothesized that early intervention with lenalidomide could delay progression to symptomatic multiple myeloma.
methodsWe conducted a randomized trial that assessed the efficacy of single-agent lenalidomide compared with observation in patients with intermediate- or high-risk smoldering multiple myeloma. Lenalidomide was administered orally at a dose of 25 mg on days 1 to 21 of a 28-day cycle. The primary end point was progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression.
resultsOne hundred eighty-two patients were randomly assigned-92 patients to the lenalidomide arm and 90 to the observation arm. Median follow-up is 35 months. Response to therapy was observed in 50% (95% CI, 39% to 61%) of patients in the lenalidomide arm, with no responses in the observation arm. Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62;
conclusionEarly intervention with lenalidomide in smoldering multiple myeloma significantly delays progression to symptomatic multiple myeloma and the development of end-organ damage.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.