Trial reportJournal of cancer research and clinical oncology2020
Frailty impairs the feasibility of induction therapy but not of maintenance therapy in elderly myeloma patients: final results of the German Maintenance Study (GERMAIN).
Trial report in Journal of cancer research and clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 3 of them syntheses that pooled it.
What it found
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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
7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- Inconsistent definitions of transplant ineligibility in multiple myeloma: A systematic review.British journal of haematology · 2026Pooled it
- Frailty as an Effect Modifier in Randomized Controlled Trials: A Systematic Review.Journal of general internal medicine · 2024Pooled it
- The prevalence and outcomes of frail older adults in clinical trials in multiple myeloma: A systematic review.Blood cancer journal · 2023Pooled it
- Advances in the application of frailty scoring in the diagnosis and management of elderly patients with multiple myeloma (Review).Oncology reports · 2026Review
- Nomogram model for predicting frailty of patients with hematologic malignancies - A cross-sectional survey.Asia-Pacific journal of oncology nursing · 2023Article
- An objective assessment in newly diagnosed multiple myeloma to avoid treatment complications and strengthen therapy adherence.Haematologica · 2023Article
- Maintenance Therapy With Bortezomib and Dexamethasone for Transplant-ineligible Patients With Multiple Myeloma.Cancer diagnosis & prognosisArticle
Corrections and comments
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Authors and funding
13 authors at 7 institutions in 1 country.
Funding
Abstract
purposeThe German Maintenance Study (GERMAIN) was designed to evaluate the impact of lenalidomide maintenance after induction therapy with bortezomib, melphalan and prednisolone (VMP) in transplant-ineligible newly diagnosed multiple myeloma (MM) patients.
methodsDue to poor accrual and high dropout rate, only 85 patients (planned 286) entered the trial and 40 (planned 200) were randomized to lenalidomide maintenance (n = 19) vs. observation (n = 21).
resultsThe primary endpoint, improved progression-free survival, was not met (p = 0.3572). After a median follow-up of 12.9 months, median progression-free survival in the lenalidomide arm was 14.4 months and 11.4 months with placebo. The hazard ratio 0.621 (95% confidence interval: [0.224, 1.725]) was about the same as expected (0.625). However, with only 40 patients randomized, the actual power to detect a difference was 11%. Of patients receiving at least one dose of induction, 54% were frail according to a modified International Myeloma Working Group frailty score. Discontinuations were high during induction (47%), and affected mainly frail patients (54%). Despite a higher rate of adverse events in the lenalidomide arm (p = 0.0061), only 2 patients discontinued lenalidomide due to toxicity.
conclusionA frailty assessment with appropriate dose modification for induction therapy should be mandatory for all elderly non-transplant-eligible myeloma patients.
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