Evidence map›Paper›PMID 33735504›Full record

ArticleCancer2021

Phase 1b trial of isatuximab, an anti-CD38 monoclonal antibody, in combination with carfilzomib as treatment of relapsed/refractory multiple myeloma.

Thomas G Martin, Nina Shah, Joshua Richter, David H Vesole, Sandy W Wong, Chiung-Yu Huang, Deepu Madduri, Sundar Jagannath, David S Siegel, Noa Biran and 7 more

Open access · hybridAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.3field-weighted citation impact, top 20% 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

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Anti CD38 monoclonal antibodies for multiple myeloma treatment.Human vaccines & immunotherapeutics · 2022
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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

17 authors at 5 institutions in 2 countries.

Thomas G MartinHematology/Oncology, University of California San Francisco Medical Center, San Francisco, California.ORCID 0000-0003-1752-5092
Nina ShahHematology/Oncology, University of California San Francisco Medical Center, San Francisco, California.ORCID 0000-0002-1971-8173
Joshua RichterHematology and Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.
David H VesoleMyeloma Division, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey.
Sandy W WongHematology/Oncology, University of California San Francisco Medical Center, San Francisco, California.
Chiung-Yu HuangDepartment of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California.
Deepu MadduriHematology and Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.
Sundar JagannathTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.ORCID 0000-0003-2934-6518
David S SiegelMyeloma Division, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey.
Noa BiranMyeloma Division, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey.
Jeffrey L WolfHematology/Oncology, University of California San Francisco Medical Center, San Francisco, California.
Samir ParekhHematology and Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.
Hearn J ChoTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
Pamela MunsterHematology/Oncology, University of California San Francisco Medical Center, San Francisco, California.
Shambavi RichardHematology and Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.
Samira Ziti-LjajicTranslational Medicine and Early Development, Pharmacokinetic and Drug Metabolism, Pharmacokinetic Unit, Sanofi, Paris, France.
Ajai ChariHematology and Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.ORCID 0000-0002-0405-7480
Icahn School of Medicine at Mount Sinai · USUniversity of California San Francisco Medical Center · USHackensack University Medical Center · USSanofi (France) · FRUniversity of California, San Francisco · US

Funding

AmgenSanofi
6 · The paper itself

Abstract

backgroundIsatuximab (Isa), an anti-CD38 monoclonal antibody, and carfilzomib (K), a next-generation proteasome inhibitor (PI), both have potent single-agent activity in relapsed and refractory multiple myeloma (RRMM).

methodsThis phase 1b study evaluated the combination of Isa and K in 33 patients with RRMM. Isa was administered by intravenous infusion in 3 dosing cohorts: dose level 1 (Isa at 10 mg/kg biweekly), dose level 2 (DL2; Isa at 10 mg/kg weekly for 4 doses and then biweekly), and dose level 3 (Isa at 20 mg/kg weekly for 4 doses and then biweekly) and all patients received K (20 mg/m

resultsWith a median follow-up of 26.7 months, in this heavily pretreated population with a median of 3 prior lines (refractory to PIs and immunomodulatory drugs, 76%; refractory to K, 27%), the overall response rate was 70% (stringent complete response/complete response, 4; very good partial response, 8; partial response, 11). The median progression-free survival was 10.1 months, and the 2-year survival probability was 76%. The most common treatment-related adverse events (grade 2 or higher) were anemia, leukopenia, neutropenia, thrombocytopenia, hypertension, and infection. Infusion reactions were common (55%) but did not limit dosing.

conclusionsTreatment with Isa plus K was well tolerated with no unexpected toxicity. The combination was effective despite the enrollment of heavily pretreated patients with RRMM. LAY SUMMARY: This phase 1b study was designed to assess the safety, pharmacokinetics, and preliminary efficacy of isatuximab and carfilzomib in patients with relapsed and refractory multiple myeloma. Thirty-three patients were treated: 15 in dose escalation and 18 in dose expansion. Patients received an average of 10 cycles. The treatment was safe and effective. No unexpected toxicity or drug-drug interactions were noted. Seventy percent of the subjects responded to therapy, and the progression-free survival was 10.1 months.

Indexed as

Antibodies, Monoclonal, HumanizedMultiple MyelomaOligopeptidesAntibodies, MonoclonalAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsHumansRecurrenceAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentscarfilzomibisatuximabOligopeptidescarfilzomibimmunomodulatoryisatuximabmonoclonal antibodypharmacokineticsproteasome

Identifiers

PMID33735504
PMCPMC8252002
OpenAlexW3137683544

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.