Evidence map›Paper›PMID 22451423›Full record

Trial reportBlood2012

Combination of bendamustine, lenalidomide, and dexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective: results of phase 1/2 open-label, dose escalation study.

Suzanne Lentzsch, Amy O'Sullivan, Ryan C Kennedy, Mohammad Abbas, Lijun Dai, Silvana Lalo Pregja, Steve Burt, Michael Boyiadzis, G David Roodman, Markus Y Mapara and 5 more

3 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 3 registered trials, which are not on this map. Cited by 52 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 1 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.

NCT01042704 phase1completednot on this map

Phase I Study of Bendamustine in Combination With Lenalidomide (CC-5013) and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma

TypeinterventionalSponsorRobert Redner, MDRan2008 to 2015Enrolled29ConditionsMyelomaArmsBendamustine, Lenalidomide, Dexamethasone, Aspirin, Prophylaxis
NCT01701076 phase2completednot on this map

An Open, Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma

TypeinterventionalSponsorCantonal Hospital of St. GallenRan2012 to 2016Enrolled50ConditionsMultiple MyelomaArmsBendamustine
NCT02416206 phase2completednot on this mapstarted 2015, after this paper: background citation

A Phase II Trial of High-dose Bendamustine, Etoposide, Cytarabine, and Melphalan (BeEAM) in the Up-front Treatment of Multiple Myeloma

TypeinterventionalSponsorNorthside Hospital, Inc.Ran2015 to 2021Enrolled65ConditionsMultiple MyelomaArmsBeEAM
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Bendamustine With Dexamethasone in Relapsed/Refractory Systemic Light-Chain Amyloidosis: Results of a Phase II Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
  4. Trial
  5. Trial
  6. A Phase I/II Study of Evofosfamide, A Hypoxia-activated Prodrug with or without Bortezomib in Subjects with Relapsed/Refractory Multiple Myeloma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Review
  20. How I treat a refractory myeloma patient who is not eligible for a clinical trial.Hematology. American Society of Hematology. Education Program · 2019
    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

15 authors.

Suzanne LentzschDepartment of Medicine, Division of Hematology/Oncology, University of Pittsburgh School of Medicine and Cancer Institute, Pittsburgh, PA, USA.
Amy O'Sullivan
Ryan C Kennedy
Mohammad Abbas
Lijun Dai
Silvana Lalo Pregja
Steve Burt
Michael Boyiadzis
G David Roodman
Markus Y Mapara
Mounzer Agha
John Waas
Yongli Shuai
Daniel Normolle
Jeffrey A Zonder

Funding

VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Jessie Nedrow · 1988 to 2026
$158.0M
NCI NIH HHS P30 CA047904NCI NIH HHS P30CA047904
6 · The paper itself

Abstract

This multicenter phase 1/2 trial investigated the combination of bendamustine, lenalidomide, and dexamethasone in repeating 4-week cycles as treatment for relapsed refractory multiple myeloma (MM). Phase 1 established maximum tolerated dose (MTD). Phase 2 assessed overall response rate at the MTD. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). A total of 29 evaluable patients were enrolled. Median age was 63 years (range, 38-80 years). Median number of prior therapies was 3 (range, 1-6). MTD was bendamustine 75 mg/m(2) (days 1 and 2), lenalidomide 10 mg (days 1-21), and dexamethasone 40 mg (weekly) of a 28-day cycle. Partial response rate was 52%, with very good partial response achieved in 24%, and minimal response in an additional 24% of patients. Median follow-up was 13 months; median OS has not been reached. One-year OS is 93% (95% confidence interval [CI], 59%-99%). Median PFS is 6.1 months (95% CI, 3.7-9.4 months) with one-year PFS of 20% (95% CI, 6%-41%). Grade 3/4 adverse events included neutropenia, thrombocytopenia, anemia, hyperglycemia, and fatigue. This first phase 1/2 trial testing bendamustine, lenalidomide, and dexamethasone as treatment of relapsed refractory MM was feasible and highly active. This study is registered at www.clinicaltrials.gov as #NCT01042704.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideDexamethasoneDose-Response Relationship, DrugDrug Resistance, NeoplasmFeasibility StudiesFemaleHumansLenalidomideMaleMiddle AgedMultiple MyelomaNitrogen Mustard CompoundsBendamustine HydrochlorideDexamethasoneLenalidomideNitrogen Mustard CompoundsThalidomide

Identifiers

PMID22451423
PMCPMC3392072

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.