Evidence map›Paper›PMID 39227452›Full record

ArticleAnnals of hematology2024

A phase Ib trial of isatuximab, bendamustine, and prednisone in relapsed/refractory multiple myeloma.

Scott R Goldsmith, Michael J Slade, Mark Fiala, Melinda Harding, Zachary D Crees, Mark A Schroeder, Keith Stockerl-Goldstein, Ravi Vij

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Annals of hematology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04083898 (A Phase I/II Trial of Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04083898 phase1terminatednot on this map

A Phase I/II Trial of Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma

TypeinterventionalSponsorWashington University School of MedicineRan2020 to 2024Enrolled15ConditionsMultiple MyelomaArmsIsatuximab, Bendamustine, Prednisone
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Monoclonal Antibodies in Relapsed-Refractory Multiple Myeloma.Pharmaceuticals (Basel, Switzerland) · 2025
    Review
  3. 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.

Scott R Goldsmith *Division of Oncology, Department of Medicine, Washington University in Saint Louis, St. Louis, MO, USA.
Michael J Slade *Division of Oncology, Department of Medicine, Washington University in Saint Louis, St. Louis, MO, USA. sladem@wustl.edu.
Mark FialaDivision of Oncology, Department of Medicine, Washington University in Saint Louis, St. Louis, MO, USA.
Melinda HardingDivision of Oncology, Department of Medicine, Washington University in Saint Louis, St. Louis, MO, USA.
Zachary D CreesDivision of Oncology, Department of Medicine, Washington University in Saint Louis, St. Louis, MO, USA.
Mark A SchroederDivision of Oncology, Department of Medicine, Washington University in Saint Louis, St. Louis, MO, USA.
Keith Stockerl-GoldsteinDivision of Oncology, Department of Medicine, Washington University in Saint Louis, St. Louis, MO, USA.
Ravi VijDivision of Oncology, Department of Medicine, Washington University in Saint Louis, St. Louis, MO, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with triple-class refractory (TCR) multiple myeloma (MM) often need cytoreductive chemotherapy for rapid disease control. Bendamustine is an outpatient-administered, bifunctional alkylator and isatuximab is an anti-CD38 monoclonal antibody with unique cytotoxicity characteristics. We hypothesized that isatuximab-bendamustine-prednisone would be well-tolerated regimen in TCR MM, and conducted single-center, phase Ib, investigator-initiated study. PATIENTS/

methodsPatients had TCR MM and last daratumumab exposure ≥ 6 weeks. This study was conducted as a 3 + 3 design to establish the maximally tolerated dose (MTD) and/or recommended phase 2 dose (RP2D). Isatuximab 10 mg/kg IV was administered weekly (cycle 1), and every 2 weeks thereafter. Bendamustine was administered on days 1 and 2 at 3 dose levels (DL): 50, 75, and 100 mg/m

resultsFifteen patients were treated (3 DL1, 6 DL2, 6 DL3). Median age was 71, 53% had high-risk cytogenetics, and 34% had prior BCMA-targeting therapy. One DLT was observed at DL2 (Grade 3 thrombocytopenia plus bleeding). There were no Grade 5 treatment-related AEs. The MTD was not reached. The overall response rate was 20% (3/15) including one stringent complete response. The median PFS was 2.5 months (95% CI 0.9-4.1 months).

conclusionWe demonstrated the safety and tolerability of isatuximab-bendamustine-prednisone. Toxicities were mild and manageable with limited intervention. The study was discontinued due to slow accrual. However, we observed responses even among highly refractory patients. CLINICAL

trial registrationThis study was registered on clinicaltrials.gov as NCT04083898 on 9/6/2019.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideMultiple MyelomaPrednisoneAgedAged, 80 and overAntibodies, Monoclonal, HumanizedDrug Resistance, NeoplasmFemaleHumansMaleMaximum Tolerated DoseMiddle AgedAntibodies, Monoclonal, HumanizedBendamustine HydrochlorideisatuximabPrednisoneBendamustineChemoimmunotherapyIsatuximabOutpatientRelapsed/refractory multiple myelomaTriple-class refractory multiple myeloma

Identifiers

PMID39227452

What OpenQuestion holds

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Registered trials

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