Trial reportInternational journal of hematology2010
Lenalidomide plus dexamethasone treatment in Japanese patients with relapsed/refractory multiple myeloma.
Trial report in International journal of hematology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00555100 (A Multicenter, Phase I Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma), which is not on this map. Cited by 23 papers.
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.
A Multicenter, Phase I Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
Who cites it
23 citing papers in PubMed.
- A phase II study of lenalidomide consolidation and maintenance therapy after autologous PBSCT in patients with multiple myeloma.International journal of hematology · 2019Trial
- Bortezomib plus dexamethasone vs thalidomide plus dexamethasone for relapsed or refractory multiple myeloma.Cancer science · 2018Trial
- Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma: A phase II study.Cancer science · 2016Trial
- Long-term use of lenalidomide and low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: MM-024 Extended Access Program.BMC cancer · 2016Trial
- Lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed or refractory multiple myeloma and renal impairment.International journal of hematology · 2015Trial
- A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial.Journal of hematology & oncology · 2013Trial
- Lenalidomide treatment of Japanese patients with myelodysplastic syndromes with 5q deletion: a post-marketing surveillance study.International journal of hematology · 2023Article
- A pilot study of 3D tissue-engineered bone marrow culture as a tool to predict patient response to therapy in multiple myeloma.Scientific reports · 2021Observational
- Immunomodulatory drugs suppress Th1-inducing ability of dendritic cells but enhance Th2-mediated allergic responses.Blood advances · 2020Article
- The immunomodulatory-drug, lenalidomide, sustains and enhances interferon-α production by human plasmacytoid dendritic cells.Journal of blood medicine · 2019Article
- Elotuzumab with lenalidomide and dexamethasone for Japanese patients with relapsed/refractory multiple myeloma: phase 1 study.International journal of hematology · 2017Article
- Clinical Pharmacokinetics and Pharmacodynamics of Lenalidomide.Clinical pharmacokinetics · 2017Review
- Myelomatous meningitis: a case report.International journal of hematology · 2016Article
- Use of lenalidomide in the management of relapsed or refractory multiple myeloma: expert recommendations in Korea.Blood research · 2015Review
- Clinical utility and patient consideration in the use of lenalidomide for multiple myeloma in Chinese patients.OncoTargets and therapy · 2015Review
- Impact of early use of lenalidomide and low-dose dexamethasone on clinical outcomes in patients with relapsed/refractory multiple myeloma.International journal of hematology · 2015Article
- Patient with refractory multiple myeloma developing eosinophilia after lenalidomide treatment and lung cancer 9 months later: case report and review of the literature.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2014Article
- Article
- Activation of coagulation by lenalidomide-based regimens for the treatment of multiple myeloma.PloS one · 2013Article
- Pharmacokinetics and tissue disposition of lenalidomide in mice.The AAPS journal · 2012Article
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We conducted a multicenter, open-label study to investigate the safety, efficacy, and pharmacokinetics of lenalidomide in Japanese patients with relapsed or refractory multiple myeloma The study was composed of the "monotherapy phase", a dose-escalation phase, to determine the tolerability to single agent lenalidomide and the "combination phase" to determine the safety and obtain preliminary data on the efficacy of lenalidomide plus dexamethasone. The primary end points were the tolerability to 25 mg lenalidomide and safety. Nine and six patients were enrolled in the monotherapy phase and the combination phase, respectively. Since 25 mg of monotherapy treatment did not satisfy the DLT criteria, this dose was employed in the combination phase. The major adverse event was myelosuppression. At the planned interim analysis (median study duration, 26.3 weeks), grade 3 or grade 4 neutropenia was observed with high frequency (66.7%). However, all adverse events observed were clinically manageable. In the combination cohort, the overall response rate (> or =PR) was 100%. The pharmacokinetics of lenalidomide showed rapid absorption and elimination after both single and multiple doses. In conclusion, 25 mg of lenalidomide was given safely as a single agent or in combination with dexamethasone in Japanese patients. The good efficacy of the combination therapy was also demonstrated in this study.
Indexed as
Identifiers
20559759What 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.