Evidence map›Paper›PMID 30190454›Full record

Trial reportBlood cancer journal2018

Lenalidomide and dexamethasone in patients with relapsed multiple myeloma and impaired renal function: PrE1003, a PrECOG study.

Joseph Mikhael, Judith Manola, Amylou C Dueck, Suzanne Hayman, Kurt Oettel, Abraham S Kanate, Sagar Lonial, S Vincent Rajkumar

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Blood cancer journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00790842 (A Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients With Impaired Renal Function), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

NCT00790842 phase1 / phase2terminatednot on this map

A Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients With Impaired Renal Function

TypeinterventionalSponsorPrECOG, LLC.Ran2009 to 2018Enrolled63ConditionsMultiple Myeloma, Plasma Cell NeoplasmArmsLenalidomide, Dexamethasone, Anticoagulants
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 24 citations in OpenAlex.

  1. Trial
  2. Review
  3. Observational
  4. Review
  5. Lenalidomide use in multiple myeloma (Review).Molecular and clinical oncology · 2024
    Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. 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

8 authors at 6 institutions in 1 country.

Joseph MikhaelMayo Clinic, Phoenix, AZ, USA. jmikhael@myeloma.org.
Judith ManolaDana-Farber Cancer Institute, Boston, MA, USA.
Amylou C DueckMayo Clinic, Phoenix, AZ, USA.
Suzanne HaymanMayo Clinic, Rochester, MN, USA.
Kurt OettelGundersen Health System, La Crosse, WI, USA.
Abraham S KanateWest Virginia University Mary Babb Randolph Cancer Center, Morgantown, WV, USA.
Sagar LonialEmory University Winship Cancer Institute, Atlanta, GA, USA.
S Vincent RajkumarMayo Clinic, Rochester, MN, USA.
Mayo Clinic Hospital · USMayo Clinic in Arizona · USDana-Farber Cancer Institute · USGundersen Health System · USWest Virginia University · USWinship Cancer Institute

Funding

Project 4: Targeting Resistance to T-Cell Directed Therapy in Multiple MyelomaP50CA186781 · NCI · MAYO CLINIC ARIZONA · PI Rafael Fonseca · 2015 to 2026
$25.5M
NCI NIH HHS P50 CA186781
6 · The paper itself

Abstract

Renal insufficiency is common in patients with relapsed multiple myeloma and can often limit choice of therapy. Lenalidomide, a critical agent in the treatment of relapsed multiple myeloma, is renally cleared., This phase I/II trial evaluated the efficacy and safety of lenalidomide with dexamethasone in patients with relapsed multiple myeloma and renal insufficiency. Three groups were treated, with creatinine clearance 30-60 cc/hr (group A), CrCl < 30 not on dialysis (group B), and patients on dialysis (group C) at escalating doses of lenalidomide. A total of 63 patients were treated and no DLTs were observed in phase I. All three groups were able to escalate to full dose lenalidomide 25 mg daily 21/28 days, although due to reduced accrual the phase II component was not entirely completed for groups B and C. Adverse events were as expected, including anemia, diarrhea and fatigue. Ten patients experienced grade 3-4 pneumonia. Overall response rate was 54% across all groups. PFS was 7.5 months and OS was 19.7 months. Lenalidomide can be given at full dose 25 mg daily 21/28 in patients with a CrCl > 30, and can be given daily to those with CrCl < 30, even when on dialysis, at doses of at least 15 mg daily.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkersDexamethasoneDrug MonitoringFemaleHumansKidney Function TestsLenalidomideMaleMiddle AgedMultiple MyelomaPrognosisRecurrenceRenal InsufficiencyBiomarkersDexamethasoneLenalidomide

Identifiers

PMID30190454
PMCPMC6127323
OpenAlexW2888850744

What OpenQuestion holds

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LicenceCC BY
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.