Evidence map›Paper›PMID 31455773›Full record

Trial reportBlood cancer journal2019

Nelfinavir and lenalidomide/dexamethasone in patients with lenalidomide-refractory multiple myeloma. A phase I/II Trial (SAKK 39/10).

F Hitz, M Kraus, T Pabst, D Hess, L Besse, T Silzle, U Novak, K Seipel, S Rondeau, S Stüdeli and 5 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Blood cancer journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.5field-weighted citation impact, top 10% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 22 citations in OpenAlex.

  1. Article
  2. Antiretroviral Drugs Impact Autophagy: Opportunities for Drug Repurposing.Frontiers in bioscience (Landmark edition) · 2024
    Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Real-World Outcome in the pre-CAR-T Era of Myeloma Patients Qualifying for CAR-T Cell Therapy.Mediterranean journal of hematology and infectious diseases · 2021
    Article
  11. Review
  12. Article
  13. 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 at 5 institutions in 1 country.

F HitzDepartment of Oncology and Hematology, Kantonsspital St.Gallen, St.Gallen, Switzerland. felicitas.hitz@kssg.ch.
M KrausDepartment of Oncology and Hematology, Kantonsspital St.Gallen, St.Gallen, Switzerland.
T PabstDepartment of Medical Oncology, Inselspital, Universitätsspital Bern, Bern, Switzerland.
D HessDepartment of Oncology and Hematology, Kantonsspital St.Gallen, St.Gallen, Switzerland.
L BesseDepartment of Oncology and Hematology, Kantonsspital St.Gallen, St.Gallen, Switzerland.
T SilzleDepartment of Oncology and Hematology, Kantonsspital St.Gallen, St.Gallen, Switzerland.
U NovakDepartment of Medical Oncology, Inselspital, Universitätsspital Bern, Bern, Switzerland.
K SeipelDepartment of Medical Oncology, Inselspital, Universitätsspital Bern, Bern, Switzerland.
S RondeauSAKK Coordinating Center, Bern, Switzerland.
S StüdeliSAKK Coordinating Center, Bern, Switzerland.
S Berardi VileiSAKK Coordinating Center, Bern, Switzerland.
P SamarasHirslanden, Zürich, Switzerland.
U MeyDepartment of Oncology, Kantonsspital Graubünden, Chur, Switzerland.
C DriessenDepartment of Oncology and Hematology, Kantonsspital St.Gallen, St.Gallen, Switzerland.
Swiss Group for Clinical Cancer Research SAKK
Kantonsspital St. Gallen · CHSwiss Group For Clinical Cancer Research · CHUniversity Hospital of Bern · CHKantonsspital Graubünden · CHKlinik Hirslanden · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The antiretroviral agent nelfinavir has antimyeloma activity and can overcome resistance to bortezomib. Our phase I/II trial investigated whether adding nelfinavir to lenalidomide-dexamethasone can overcome lenalidomide resistance in lenalidomide-refractory multiple myeloma (MM). Twenty-nine patients were included (high-risk cytogenetic aberrations 31%; ≥2 prior therapy lines 93%; lenalidomide-bortezomib double-refractory 34%). Twenty-four patients (83%) had prior bortezomib and 10 (34%) were lenalidomide-bortezomib double-refractory. They received four cycles of nelfinavir 2500 mg/day with standard-dose lenalidomide (25 mg days 1-21) and dexamethasone (40/20 mg days 1, 8, 15, 22). Minor response or better was achieved in 16 patients (55%; 95% CI 36-74%), including 40% of those who were lenalidomide-bortezomib double-refractory, and partial response or better in nine patients (31%; 95% CI 15-51%). Median progression-free survival was 3.4 (95% CI 2.0-4.9) months and median overall survival 21.6 (13.0-50.1) months. Lenalidomide-related pneumonitis, pneumonia, and neutropenic fever occurred, but there were no unexpected adverse events. Peripheral blood mononuclear cells showed a 45% (95% CI 40-51%) reduction in total proteasome activity from baseline and significant induction of unfolded protein response and autophagy. Thus, nelfinavir-lenalidomide-dexamethasone is an active oral combination in lenalidomide-refractory MM.

Indexed as

AdultAgedAged, 80 and overAnti-Inflammatory AgentsDexamethasoneFemaleHIV Protease InhibitorsHumansLenalidomideMaleMiddle AgedMultiple MyelomaNelfinavirAnti-Inflammatory AgentsDexamethasoneHIV Protease InhibitorsLenalidomideNelfinavir

Identifiers

PMID31455773
PMCPMC6711992
OpenAlexW2971282834

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.