Evidence map›Paper›PMID 22665938›Full record

Trial reportBlood2012

A phase 1/2 study of carfilzomib in combination with lenalidomide and low-dose dexamethasone as a frontline treatment for multiple myeloma.

Andrzej J Jakubowiak, Dominik Dytfeld, Kent A Griffith, Daniel Lebovic, David H Vesole, Sundar Jagannath, Ammar Al-Zoubi, Tara Anderson, Brian Nordgren, Kristen Detweiler-Short and 9 more

2 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood, 2012. 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 183 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
183citing papers in PubMed, 6 pooled it
–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.

NCT01029054 phase1 / phase2completednot on this map

Multicenter, Open-label, Single-arm, Phase 1b/2 Study of the Safety and Efficacy of Combination Treatment w/ Carfilzomib, Lenalidomide (Revlimid®) and Dexamethasone (CRD) in Subjects w/ Newly Diagnosed, Previously Untreated Multiple Myeloma Requiring Systemic Chemotherapy

TypeinterventionalSponsorUniversity of Michigan Rogel Cancer CenterRan2009 to 2015Enrolled53ConditionsMultiple MyelomaArmscarfilzomib, lenalidomide plus dexamethasone
NCT03992170 phase2unknown statusnot on this mapstarted 2018, after this paper: background citation

A Pilot Study on the Efficacy of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive by Next Generation Flow

TypeinterventionalSponsorAzienda Ospedaliera Universitaria SeneseRan2018 to 2022Enrolled50ConditionsMyeloma MultipleArmsDaratumumab
3 · Its place in the literature

Who cites it

183 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Lenalidomide Maintenance After Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Meta-Analysis.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2017
    Pooled it
  4. Pooled it
  5. NCCN Guidelines Insights: Multiple Myeloma, Version 3.2016.Journal of the National Comprehensive Cancer Network : JNCCN · 2016
    Guideline
  6. Multiple Myeloma, Version 2.2016: Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2015
    Guideline
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  19. Once-weeklyHaematologica · 2019
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123 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Andrzej J JakubowiakUniversity of Chicago Medical Center, Chicago, IL 60637-6613, USA. ajakubowiak@medicine.bsd.uchicago.edu
Dominik Dytfeld
Kent A Griffith
Daniel Lebovic
David H Vesole
Sundar Jagannath
Ammar Al-Zoubi
Tara Anderson
Brian Nordgren
Kristen Detweiler-Short
Keith Stockerl-Goldstein
Asra Ahmed
Terri Jobkar
Diane E Durecki
Kathryn McDonnell
Melissa Mietzel
Daniel Couriel
Mark Kaminski
Ravi Vij

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI THEODORE S LAWRENCE · 1988 to 2026
$178.2M
NCI NIH HHS P30 CA046592
6 · The paper itself

Abstract

This phase 1/2 study in patients with newly diagnosed multiple myeloma (N = 53) assessed CRd--carfilzomib (20, 27, or 36 mg/m2, days 1, 2, 8, 9, 15, 16 and 1, 2, 15, 16 after cycle 8), lenalidomide (25 mg/d, days 1-21), and weekly dexamethasone (40/20 mg cycles 1-4/5+)--in 28-day cycles. After cycle 4, transplantation-eligible candidates underwent stem cell collection (SCC) then continued CRd with the option of transplantation. The maximum planned dose level (carfilzomib 36 mg/m2) was expanded in phase 2 (n = 36). Thirty-five patients underwent SCC, 7 proceeded to transplantation, and the remainder resumed CRd. Grade 3/4 toxicities included hypophosphatemia (25%), hyperglycemia (23%), anemia (21%), thrombocytopenia (17%), and neutropenia (17%); peripheral neuropathy was limited to grade 1/2 (23%). Most patients did not require dose modifications. After a median of 12 cycles (range, 1-25), 62% (N = 53) achieved at least near-complete response (CR) and 42% stringent CR. Responses were rapid and improved during treatment. In 36 patients completing 8 or more cycles, 78% reached at least near CR and 61% stringent CR. With median follow-up of 13 months (range, 4-25 months), 24-month progression-free survival estimate was 92%. CRd was well tolerated with exceptional response rates. This study is registered at http://www.clinicaltrials.gov as NCT01029054.

Indexed as

AdultAgedAged, 80 and overAnemiaAntineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyDexamethasoneDose-Response Relationship, DrugDrug Administration ScheduleFemaleHematopoietic Stem Cell TransplantationHumansHyperglycemiaHypophosphatemiaKaplan-Meier EstimateLenalidomidecarfilzomibDexamethasoneLenalidomideOligopeptidesThalidomide

Identifiers

PMID22665938
PMCPMC5162553

What OpenQuestion holds

Textmetadata
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.