Evidence map›Paper›PMID 35876974›Full record

ArticleAdvances in therapy2022

Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma.

Jianming He, Heather Berringer, Bart Heeg, Haoyao Ruan, Tobias Kampfenkel, Harikumaran R Dwarakanathan, Stephen Johnston, João Mendes, Annette Lam, Sacheeta Bathija and 1 more

3 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 34% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT01998971 phase1completednot on this map

An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Regimens for the Treatment of Subjects With Multiple Myeloma

TypeinterventionalSponsorJanssen Research & Development, LLCRan2014 to 2024Enrolled240ConditionsMultiple MyelomaArmsDaratumumab, Velcade, Pomalidomide, Dexamethasone, Melphalan
NCT02136134 phase3completednot on this map

Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Subjects With Relapsed or Refractory Multiple Myeloma

TypeinterventionalSponsorJanssen Research & Development, LLCRan2014 to 2024Enrolled498ConditionsMultiple MyelomaArmsDaratumumab, VELCADE (Bortezomib), Dexamethasone
NCT03180736 phase3completednot on this map

A Phase 3 Study Comparing Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With RRMM Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor.

TypeinterventionalSponsorStichting European Myeloma NetworkRan2017 to 2024Enrolled304ConditionsMultiple MyelomaArmsDaratumumab, Pomalidomide, Dexamethasone
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
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

11 authors at 4 institutions in 2 countries.

Jianming HeJanssen Global Services, 700 US Route 202 South, Raritan, NJ, 08869, USA. jhe2@its.jnj.com.ORCID http://orcid.org/0000-0002-5015-3713
Heather BerringerCytel, Inc, Vancouver, BC, Canada.
Bart HeegIngress Health, Rotterdam, The Netherlands.
Haoyao RuanCytel, Inc., Toronto, ON, Canada.
Tobias KampfenkelJanssen Research & Development, Neuss, Germany.
Harikumaran R DwarakanathanMu Sigma Business Solutions, LLC, Bangalore, India.
Stephen JohnstonMedical Device Epidemiology and Real-World Data Sciences, Johnson & Johnson, New Brunswick, NJ, USA.
João MendesJan-Cilag Farmacêutica, Porto Salvo, Portugal.
Annette LamJanssen Global Services, 700 US Route 202 South, Raritan, NJ, 08869, USA.
Sacheeta BathijaJanssen Global Services, 700 US Route 202 South, Raritan, NJ, 08869, USA.
Emma K MackayCytel, Inc., Toronto, ON, Canada.
Janssen (United States) · USJanssen (Germany) · DEJohnson & Johnson (United States) · USSigma Engineering (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe phase 3 APOLLO study demonstrated significantly better progression-free survival (PFS) and clinical responses with daratumumab, pomalidomide, and dexamethasone (D-Pd) versus pomalidomide and dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM). On the basis of these results and those from the phase 1b EQUULEUS trial, D-Pd was approved in this patient population. In the absence of head-to-head data comparing D-Pd with further standard of care (SOC) therapies, indirect treatment comparisons (ITCs) can provide important information to help optimize treatment selection. The objective of this study was to indirectly compare PFS improvement with D-Pd versus daratumumab, bortezomib, and dexamethasone (D-Vd) and D-Pd versus bortezomib and dexamethasone (Vd) in patients with RRMM.

methodsPatient-level data were from APOLLO, EQUULEUS, and CASTOR. Three methods of adjusting imbalances in baseline characteristics including stabilized inverse probability of treatment weighting (sIPTW), cardinality matching (CM), and propensity score matching (PSM) were initially considered. CM offers mathematically guaranteed largest matched sample meeting pre-specified maximum standardized mean difference criteria for matching covariates. sIPTW and PSM were based on propensity scores derived from logistic regression. Feasibility assessment of the PSM method returned too low effective sample size to support a meaningful comparison. CM was chosen as the base case and sIPTW as a sensitivity analysis.

resultsAfter harmonized eligibility criteria were applied, 253, 104, and 122 patients from the D-Pd, D-Vd, and Vd cohorts, respectively, were included in the ITC analyses. Some imbalances in baseline characteristics were identified between D-Pd and D-Vd/Vd cohorts that remained after adjustment. PFS hazard ratios showed significant improvement for D-Pd over D-Vd and Vd for CM and sIPTW analyses.

conclusionsResults showed consistent PFS benefit for D-Pd versus D-Vd and Vd regardless of the adjustment technique used. These findings support the use of D-Pd versus D-Vd or Vd in patients with difficult-to-treat RRMM.

trial registrationNCT03180736; NCT02136134, NCT01998971.

Indexed as

Multiple MyelomaAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBortezomibClinical Trials, Phase I as TopicClinical Trials, Phase III as TopicDexamethasoneHumansNeoplasm Recurrence, LocalStandard of CareThalidomideAntibodies, MonoclonalBortezomibdaratumumabDexamethasonepomalidomideThalidomideDaratumumabIndirect treatment comparisonMultiple myeloma

Identifiers

PMID35876974
PMCPMC9402768
OpenAlexW4287308483

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.