Trial reportCancer2016
Final overall survival results of a randomized trial comparing bortezomib plus pegylated liposomal doxorubicin with bortezomib alone in patients with relapsed or refractory multiple myeloma.
Trial report in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 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.
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, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- Effect modification in network meta-analyses for relapsed/refractory multiple myeloma: systematic review and meta-analysis.BMJ open · 2023Pooled it
- The proteasome as a druggable target with multiple therapeutic potentialities: Cutting and non-cutting edges.Pharmacology & therapeutics · 2020Pooled it
- A Phase I/II Trial of Carfilzomib, Pegylated Liposomal Doxorubicin, and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019Trial
- Nanomedicine-Based Strategies for Multiple Myeloma Therapy.International journal of nanomedicine · 2026Review
- An overview of randomized phase III clinical trials of cancer nanomedicines.Cancer pathogenesis and therapy · 2025Review
- BQ-AurIPr: a redox-active anticancer Au(i) complex that induces immunogenic cell death.Chemical science · 2022Article
- Re: Arcuri and Americo "Treatment of relapsed/refractory multiple myeloma in the bortezomib and lenalidomide era: a systematic review and network meta-analysis".Annals of hematology · 2022Article
- Pathogenesis and treatment of multiple myeloma.MedComm · 2022Review
- Article
- Targeted Drug Delivery for the Treatment of Blood Cancers.Molecules (Basel, Switzerland) · 2022Review
- Reappraisal of anticancer nanomedicine design criteria in three types of preclinical cancer models for better clinical translation.Biomaterials · 2021Article
- Pegylated Liposomal Doxorubicin in Vindesine-Based and Bortezomib-Based Regimens for Patients With Newly Diagnosed Multiple Myeloma: A Retrospective Study of Efficacy and Safety.Frontiers in oncology · 2021Article
- Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology.Oncoimmunology · 2020Review
- Modeling Covariate-Adjusted Survival for Economic Evaluations in Oncology.PharmacoEconomics · 2019Article
- Treatment options for refractory/relapsed multiple myeloma: an updated evidence synthesis by network meta-analysis.Cancer management and research · 2018Article
- Drugs that lack single-agent activity: are they worth pursuing in combination?Nature reviews. Clinical oncology · 2017Article
- Network meta-analysis of randomized trials in multiple myeloma: efficacy and safety in relapsed/refractory patients.Blood advances · 2017Article
- Review
Corrections and comments
- Commented on by
Authors and funding
16 authors at 14 institutions in 9 countries.
Funding
Abstract
backgroundPrevious results from an interim analysis of an open-label, randomized, phase 3 study demonstrated that bortezomib combined with pegylated liposomal doxorubicin (PLD) was superior to bortezomib monotherapy in patients with relapsed/refractory multiple myeloma who had previously received one or more lines of therapy. Protocol-defined final survival data from that study are provided here.
methodsPatients were randomized (1:1) to receive either bortezomib alone (1.3 mg/m(2) intravenously on days 1, 4, 8, and 11 of every 21-day cycle) or bortezomib-PLD (bortezomib plus PLD 30 mg/m(2) intravenously on day 4). The primary endpoint was the time to progression. Secondary efficacy endpoints included overall survival (OS), progression-free survival, and the overall response rate.
resultsIn total, 646 patients (bortezomib-PLD, n = 324; bortezomib alone, n = 322) were randomized between December, 2004, and March, 2006. On the clinical cutoff date (May 16, 2014) for the final survival analysis, at a median follow-up of 103 months, 79% of patients had died (bortezomib-PLD group: 253 of 324 patients; 78%; bortezomib alone group: 257 of 322 patients; 80%). The median OS in the bortezomib-PLD group was 33 months (95% confidence interval [CI], 28.9-37.1) versus 30.8 months (95% CI, 25.2-36.5) in the bortezomib alone group (hazard ratio, 1.047; 95% CI, 0.879-1.246; P = .6068). Salvage therapies included conventional and novel drugs, which were well balanced between the two treatment groups.
conclusionsDespite inducing a superior time to progression, long-term follow-up revealed that PLD-bortezomib did not improve OS compared with bortezomib alone in patients with relapsed/refractory multiple myeloma. The inability to sustain the early observed survival advantage may have been caused by the effects of subsequent lines of therapy, and underscores the need for long-term follow-up of phase 3 trials while recognizing the challenge of having adequate power to detect long-term differences in OS. Cancer 2016;122:2050-6. © 2016 American Cancer Society.
Indexed as
Identifiers
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.