Evidence map›Paper›PMID 30926770›Full record

ArticleBlood cancer journal2019

Phase I trial of isatuximab monotherapy in the treatment of refractory multiple myeloma.

Thomas Martin, Stephen Strickland, Martha Glenn, Eric Charpentier, Hélène Guillemin, Karl Hsu, Joseph Mikhael

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Blood cancer journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04943302 (Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis), which is not on this map. Cited by 52 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 2 pooled it
11.9field-weighted citation impact, top 1% 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.

NCT04943302 phase2withdrawnnot on this mapstarted 2022, after this paper: background citation

Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis

TypeinterventionalSponsorTufts Medical CenterRan2022 to 2026Enrolled0ConditionsAmyloidosis, Light Chain (AL) AmyloidosisArmsBendamustine Hydrochloride, Isatuximab
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 2 syntheses or guidelines pooled it, 104 citations in OpenAlex.

  1. Pooled it
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  14. Monoclonal Antibodies in Relapsed-Refractory Multiple Myeloma.Pharmaceuticals (Basel, Switzerland) · 2025
    Review
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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

7 authors at 5 institutions in 2 countries.

Thomas MartinUniversity of California at San Francisco, San Francisco, CA, USA. tmartin@medicine.ucsf.edu.
Stephen StricklandVanderbilt-Ingram Cancer Center, Nashville, TN, USA.
Martha GlennHuntsman Cancer Institute, Salt Lake City, UT, USA.
Eric CharpentierSanofi, Cambridge, MA, USA.
Hélène GuilleminSanofi, Vitry, France.
Karl HsuSanofi, Cambridge, MA, USA.
Joseph MikhaelCity of Hope Cancer Center and International Myeloma Foundation, Los Angeles, CA, USA.
Sanofi (United States) · USCity Of Hope National Medical Center · USHuntsman Cancer Institute · USSanofi (France) · FRVanderbilt-Ingram Cancer Center

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase I dose-escalation/expansion study evaluated isatuximab (anti-CD38 monoclonal antibody) monotherapy in patients with relapsed/refractory multiple myeloma (RRMM). Patients progressing on or after standard therapy received intravenous isatuximab (weekly [QW] or every 2 weeks [Q2W]). The primary objective was to determine the maximum tolerated dose (MTD) of isatuximab. Overall, 84 patients received ≥ 1 dose of isatuximab. The MTD was not reached; no cumulative adverse reactions were noted. The most frequent adverse events were infusion reactions (IRs), occurring in 37/73 patients (51%) following introduction of mandatory prophylaxis. IRs were mostly grade 1/2, occurred predominantly during Cycle 1, and led to treatment discontinuation in two patients. CD38 receptor occupancy reached a plateau of 80% with isatuximab 20 mg/kg (highest dose tested) and was associated with clinical response. In patients receiving isatuximab ≥ 10 mg/kg, overall response rate (ORR) was 23.8% (15/63), including one complete response. In high-risk patients treated with isatuximab 10 mg/kg (QW or Q2W), ORR was 16.7% (3/18). Median (range) duration of response at doses ≥ 10 mg/kg was 25 (8-30) weeks among high-risk patients versus 36 (6-85) weeks for other patients. In conclusion, isatuximab demonstrated a manageable safety profile and clinical activity in patients with RRMM.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedFemaleHumansMaleMiddle AgedMultiple MyelomaAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedisatuximab

Identifiers

PMID30926770
PMCPMC6440961
OpenAlexW2927473213

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.