Evidence map›Paper›PMID 42661196›Full record

Trial reportTrials2026

Interim analysis in clinical trials: caution against premature conclusions-the SWOG multiple myeloma S0777 case study.

Emily Goren, Rachael Sexton, Robert Z Orlowski, Antje Hoering

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from 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.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Emily GorenCancer Research And Biostatistics, Seattle, WA, USA.
Rachael SextonCancer Research And Biostatistics, Seattle, WA, USA.
Robert Z OrlowskiDepartment of Lymphoma - Myeloma, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX , USA.
Antje HoeringCancer Research And Biostatistics, Seattle, WA, USA. antje@crab.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInterim monitoring for efficacy and futility provides critical decision-making boundaries on early termination of randomized clinical trials. Such analyses can accelerate access to effective therapies and limit exposure to ineffective ones, but this must be weighed against premature closure that can risk obscuring a true treatment benefit. We discuss these considerations and present a case study highlighting the importance of following a well-designed interim analysis plan. METHODS AND

findingsSWOG Cancer Research Network (SWOG) S0777 was a randomized phase III study of bortezomib, lenalidomide, and dexamethasone (VRd) versus Rd in newly diagnosed multiple myeloma that incorporated two pre-planned interim analyses. At both interim analyses, while the futility stopping boundaries were not crossed, the accumulating data suggested a limited or diminishing benefit in progression-free survival (PFS). In contrast, at final analysis, VRd demonstrated significant improvement in both PFS (hazard ratio (HR) = 0.71, p = 0.0018) and overall survival (HR = 0.71, p = 0.025) compared to Rd, helping establish VRd as standard of care. Retrospective analysis shows that use of common alternative futility stopping rules would have also not been crossed, despite the lack of positive results at the interim analysis.

conclusionsS0777's success underscores the importance of pre-specified interim monitoring plans and cautions against premature trial termination.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsEarly Termination of Clinical TrialsEndpoint DeterminationMultiple MyelomaResearch DesignBortezomibDexamethasoneHumansLenalidomideProgression-Free SurvivalTime FactorsTreatment OutcomeBortezomibDexamethasoneLenalidomide

Identifiers

PMID42661196
PMCPMC13520253

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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.