Evidence map›Paper›PMID 35846097›Full record

ArticleEJHaem2021

Comparative efficacy and safety of bortezomib, thalidomide, and dexamethasone (VTd) without and with daratumumab (D-VTd) in CASSIOPEIA versus VTd in PETHEMA/GEM in transplant-eligible patients with newly diagnosed multiple myeloma, using propensity score matching.

Philippe Moreau, Cyrille Hulin, Sonja Zweegman, Mahmoud Hashim, Yannan Hu, Bart Heeg, Carla de Boer, Veronique Vanquickelberghe, Tobias Kampfenkel, Jianming He and 3 more

2 registry-linked trialsAbstract read
In one paragraph

Article in EJHaem, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT00461747 phase3completednot on this map

A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With VBMCP-VBAD/Velcade Versus Thalidomide / Dexamethasone Versus Velcade / Thalidomide / Dexamethasone Followed by High Dose Intensive Therapy With Autologous Hemopoietic Stem Cell Support and Maintenance Treatment With Interferon-a Versus Thalidomide Versus Thalidomide / Velcade in Untreated Patients With Multiple Myeloma Less Than 65 Yrs Old

TypeinterventionalSponsorPETHEMA FoundationRan2006 to 2008Enrolled390ConditionsMultiple MyelomaArmsVBMCP/VBAD/Velcade, Thalidomide/Dexamethasone, Velcade/Thalidomide/Dexamethasone
NCT02541383 phase3completednot on this map

Study of Daratumumab in Combination With Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects With Newly Diagnosed Multiple Myeloma

TypeinterventionalSponsorIntergroupe Francophone du MyelomeRan2015 to 2023Enrolled1,085ConditionsMultiple MyelomaArmsBortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD), Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab, Daratumumab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
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

13 authors.

Philippe MoreauNantes University Hospital Hôtel-Dieu Nantes France.
Cyrille HulinHospital Center University De Bordeaux Bordeaux France.
Sonja ZweegmanAmsterdam UMC, Vrije Universiteit Amsterdam Cancer Center Amsterdam Amsterdam The Netherlands.
Mahmoud HashimIngress Health Rotterdam The Netherlands.
Yannan HuIngress Health Rotterdam The Netherlands.
Bart HeegIngress Health Rotterdam The Netherlands.
Carla de BoerJanssen Research & Development Leiden The Netherlands.
Veronique VanquickelbergheJanssen Research & Development Beerse Belgium.
Tobias KampfenkelJanssen Research & Development Leiden The Netherlands.
Jianming HeJanssen Global Services LLC Raritan New Jersey USA.ORCID https://orcid.org/0000-0002-5015-3713
Annette LamJanssen Global Services LLC Raritan New Jersey USA.
Sarah CoteJanssen Global Services LLC Raritan New Jersey USA.
Pieter SonneveldErasmus MC Cancer Institute Rotterdam The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Traditional bortezomib, thalidomide, and dexamethasone (VTd) regimens for patients with newly diagnosed multiple myeloma (NDMM) include doses of thalidomide up to 200 mg/day (VTd-label). Clinical practice has evolved to use a lower dose (100 mg/day) to reduce toxicity (VTd-mod), which was evaluated in the phase III CASSIOPEIA study, without or with daratumumab (D-VTd; an anti-CD38 monoclonal antibody). We used propensity score matching to compare efficacy and safety for VTd-mod and D-VTd with VTd-label. Methods: Patient-level data for VTd-mod and D-VTd from CASSIOPEIA (NCT02541383) and data for VTd-label from the PETHEMA/GEM study (NCT00461747) were analyzed. Propensity scores were estimated using logistic regression, and nearest-neighbor matching procedure was used. Outcomes included overall survival (OS), progression-free survival (PFS), time to progression (TTP), postinduction and posttransplant responses, as well as rate of treatment discontinuation and grade 3/4 peripheral neuropathy. Results: VTd-mod was noninferior to VTd-label for OS, PFS, TTP, postinduction very good partial response or better (≥VGPR) and overall response rate (ORR). VTd-mod was significantly better for posttransplant ≥VGPR and ORR versus VTd-label. VTd-mod safety was not superior to VTd-label despite the lower thalidomide dose. D-VTd was significantly better than VTd-label for OS, PFS, TTP, postinduction and posttransplant ≥VGPR and ORR, and was noninferior to VTd-label for safety outcomes. Conclusions: In transplant-eligible patients with NDMM, D-VTd had superior efficacy compared with VTd-label. Despite a lower dose of thalidomide, VTd-mod was noninferior to VTd-label for safety and was significantly better for posttransplant ≥VGPR/ORR. These data further support the first-line use of daratumumab plus VTd.

Indexed as

clinical trialsmonoclonal antibodiesmultiple myelomathalidomide

Identifiers

PMID35846097
PMCPMC9175692

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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.