Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010
Reiterative survival analyses of total therapy 2 for multiple myeloma elucidate follow-up time dependency of prognostic variables and treatment arms.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.
- First-line tandem high-dose chemotherapy and autologous stem cell transplantation versus single high-dose chemotherapy and autologous stem cell transplantation in multiple myeloma, a systematic review of controlled studies.The Cochrane database of systematic reviews · 2012Pooled it
- Soft-tissue extramedullary multiple myeloma prognosis is significantly worse in comparison to bone-related extramedullary relapse.Haematologica · 2014Trial
- A Case of Extramedullary Plasmacytoma in Both Maxillary Sinuses.Journal of rhinology : official journal of the Korean Rhinologic Society · 2023Article
- [Clinical characteristics and outcomes of patients newly diagnosed with multiple myeloma with extramedullary disease].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2020Article
- Multiple Extramedullary Plasmacytoma in a Setting of Complete Bone Marrow Remission: Food for Thought.International journal of hematology-oncology and stem cell research · 2017Article
- Optimizing current and emerging therapies in multiple myeloma: a guide for the hematologist.Therapeutic advances in hematology · 2017Review
- Article
- Does an NKT-cell-based immunotherapeutic approach have a future in multiple myeloma?Oncotarget · 2016Review
- Consolidation and maintenance therapy for multiple myeloma after autologous transplantation: where do we stand?Bone marrow transplantation · 2015Review
- Mechanisms of Drug Resistance in Relapse and Refractory Multiple Myeloma.BioMed research international · 2015Review
- Chromosome 1 abnormalities in elderly patients with newly diagnosed multiple myeloma treated with novel therapies.Haematologica · 2014Article
- Review
- [Therapy of multiple myeloma. What is confirmed?].Der Internist · 2013Review
- Metronomic therapy is an effective salvage treatment for heavily pre-treated relapsed/refractory multiple myeloma.Haematologica · 2013Article
- Stem cell transplantation for multiple myeloma: current and future status.Leukemia supplements · 2013Review
- Developing and validating continuous genomic signatures in randomized clinical trials for predictive medicine.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Article
- Latest advances and current challenges in the treatment of multiple myeloma.Nature reviews. Clinical oncology · 2012Review
Corrections and comments
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
Abstract
purposeIn Total Therapy 2, after randomly assigning 323 patients with myeloma to thalidomide and 345 to a control arm, no difference was observed in overall survival, with a median follow-up of 42 months, although at 72 months, survival was superior on the thalidomide arm in the one third exhibiting cytogenetic abnormalities (CA). After further follow-up of 87 months, we examined, in reiterative analyses, the effect of increasing time intervals on clinical outcomes relevant to baseline prognostic variables and treatment randomization. PATIENTS AND
methodsWe investigated clinical trial end points as a function of increasing time intervals from protocol enrollment to determine consistencies of results by treatment and prognostic variables.
resultsThe complete congruence of serial survival plots for both study arms combined attested to stable patient characteristics over the time of accrual and the quality of follow-up management. Presence of CA was associated with consistently inferior survival curves from year 3 onward. Although 80% of patients randomly assigned to thalidomide discontinued study drug after 2 years because of toxicity, its clinical benefit did not reach statistical significance until year 10. The relative ranking order in multivariate models of prognostic factors remained stable over time. Decline in initially high hazard ratio values of gene array-defined high risk is consistent with an initial crisis phase that is time limited.
conclusionReporting potentially time-sensitive features as a part of clinical trial results will enable the critical reader to judge the robustness of prognostic factors and the time sensitivity of outcome predictors, with important implications for future trial designs.
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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.