Trial reportLeukemia2016
A phase 2 study of three low-dose intensity subcutaneous bortezomib regimens in elderly frail patients with untreated multiple myeloma.
Trial report in Leukemia, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 of them syntheses 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
18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- The prevalence and outcomes of frail older adults in clinical trials in multiple myeloma: A systematic review.Blood cancer journal · 2023Pooled it
- Outcome of paraosseous extra-medullary disease in newly diagnosed multiple myeloma patients treated with new drugs.Haematologica · 2020Pooled it
- Subcutaneous versus Intravenous Bortezomib Administration for Multiple Myeloma Patients: a Meta-analysis.Current medical science · 2018Pooled it
- Prospective, multicentre phase II study to evaluate the clinical benefit of reduced-dose lenalidomide and dexamethasone based on frailty stratification in elderly, unfit patients with newly diagnosed multiple myeloma.British journal of haematology · 2026Trial
- Bortezomib maintenance therapy in transplant-ineligible myeloma patients who plateaued after bortezomib-based induction therapy: a multicenter phase II clinical trial.International journal of hematology · 2018Trial
- Article
- Advantages of multi-arm non-randomised sequentially allocated cohort designs for Phase II oncology trials.British journal of cancer · 2022Article
- Outcomes of bortezomib combination chemotherapies in autologous stem cell transplantation-ineligible patients with AL amyloidosis.Blood research · 2021Article
- Octogenarian newly diagnosed multiple myeloma patients without geriatric impairments: the role of age >80 in the IMWG frailty score.Blood cancer journal · 2021Article
- Review
- Special considerations for the treatment of multiple myeloma according to advanced age, comorbidities, frailty and organ dysfunction.Critical reviews in oncology/hematology · 2019Review
- Approach to the Older Adult With Multiple Myeloma.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2019Article
- Approach to the treatment of the older, unfit patient with myeloma from diagnosis to relapse: perspectives of a US hematologist and a geriatric hematologist.Hematology. American Society of Hematology. Education Program · 2018Review
- Clinical outcomes of bortezomib-based therapy in myeloma.PloS one · 2018Article
- Current and New Therapeutic Strategies for Relapsed and Refractory Multiple Myeloma: An Update.Drugs · 2018Review
- Addition of cyclophosphamide and higher doses of dexamethasone do not improve outcomes of patients with AL amyloidosis treated with bortezomib.Blood cancer journal · 2017Article
- Geriatric Assessment to Predict Survival and Risk of Serious Adverse Events in Elderly Newly Diagnosed Multiple Myeloma Patients: A Multicenter Study in China.Chinese medical journal · 2017Article
- Myeloma in Elderly Patients: When Less Is More and More Is More.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
30 authors at 17 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This phase 2 trial evaluated three low-dose intensity subcutaneous bortezomib-based treatments in patients ⩾75 years with newly diagnosed multiple myeloma (MM). Patients received subcutaneous bortezomib plus oral prednisone (VP, N=51) or VP plus cyclophosphamide (VCP, N=51) or VP plus melphalan (VMP, N=50), followed by bortezomib maintenance, and half of the patients were frail. Response rate was 64% with VP, 67% with VCP and 86% with VMP, and very good partial response rate or better was 26%, 28.5% and 49%, respectively. Median progression-free survival was 14.0, 15.2 and 17.1 months, and 2-year OS was 60%, 70% and 76% in VP, VCP, VMP, respectively. At least one drug-related grade ⩾3 non-hematologic adverse event (AE) occurred in 22% of VP, 37% of VCP and 33% of VMP patients; the discontinuation rate for AEs was 12%, 14% and 20%, and the 6-month rate of toxicity-related deaths was 4%, 4% and 8%, respectively. The most common grade ⩾3 AEs included infections (8-20%), and constitutional (10-14%) and cardiovascular events (4-12%); peripheral neuropathy was limited (4-6%). Bortezomib maintenance was effective and feasible. VP, VCP and VMP regimens demonstrated no substantial difference. Yet, toxicity was higher with VMP, suggesting that a two-drug combination followed by maintenance should be preferred in frail patients.
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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.