Trial reportBlood2021
Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma.
Trial report in Blood, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01084252 (A Phase I/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody), which is not on this map. Cited by 45 papers, 2 of them syntheses that pooled 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.
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.
A Phase I/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 in Patients With Selected CD38+ Hematological Malignancies
Who cites it
45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 82 citations in OpenAlex.
- Cluster of differentiation 38 monoclonal antibody therapy in the treatment of multiple myeloma: a systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- Effect modification in network meta-analyses for relapsed/refractory multiple myeloma: systematic review and meta-analysis.BMJ open · 2023Pooled it
- Isatuximab in combination with cemiplimab in patients with relapsed/refractory multiple myeloma: A phase 1/2 study.Cancer medicine · 2023Trial
- Cardiovascular Toxicity of Monoclonal Antibodies Approved for Multiple Myeloma: Evidence Based on FAERS Database.Therapeutic innovation & regulatory science · 2026Article
- Review
- Efficacy and Safety of Isatuximab Combination Therapy in Multiple Myeloma: A Meta-Analysis of Randomized Controlled Trials.Cancers · 2025Review
- Efficacy and safety of isatuximab monotherapy to treat relapsed or refractory multiple myeloma: a pooled analysis of clinical trials.Annals of hematology · 2025Article
- Targets Selection for Precision Therapy of Relapsed/Refractory Multiple Myeloma: the Latest Advancements.Current treatment options in oncology · 2025Review
- Relative Dose Intensity of Daratumumab, Lenalidomide, and Dexamethasone in Multiple Myeloma.Cancers · 2025Article
- Monoclonal Antibodies in Relapsed-Refractory Multiple Myeloma.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Efficacy of elotuzumab for multiple myeloma deteriorates after daratumumab: a multicenter retrospective study.Annals of hematology · 2024Article
- Article
- Phase 1 study of isatuximab monotherapy in Chinese patients with relapsed/refractory multiple myeloma.Scientific reports · 2024Article
- Challenges in the treatment of soft-tissue plasmacytoma: a retrospective analysis of 120 patients with extramedullary multiple myeloma.Journal of cancer research and clinical oncology · 2024Article
- Isatuximab with pomalidomide-dexamethasone in relapsed/refractory multiple myeloma: post-marketing surveillance in Japan.International journal of hematology · 2024Article
- The lymphocyte/monocyte ratio predicts the efficacy of isatuximab plus pomalidomide in multiple myeloma patients.Cancer immunology, immunotherapy : CII · 2024Article
- Model-based simulation to support the approval of isatuximab alone or with dexamethasone for the treatment of relapsed/refractory multiple myeloma in Japanese patients.CPT: pharmacometrics & systems pharmacology · 2023Article
- IMiD-Free Interval and IMiDs Sequence: Which Strategy Is Better Suited for Lenalidomide-Refractory Myeloma?Life (Basel, Switzerland) · 2023Review
- CD38 antibody re-treatment in daratumumab-refractory multiple myeloma after time on other therapies.Blood advances · 2023Article
- Immunomodulatory properties of CD38 antibodies and their effect on anticancer efficacy in multiple myeloma.Cancer medicine · 2023Review
Corrections and comments
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Authors and funding
17 authors at 15 institutions in 10 countries.
Funding
Abstract
This phase 2 study evaluated isatuximab as monotherapy or combined with dexamethasone in relapsed/refractory multiple myeloma (RRMM). Patients had RRMM refractory to an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) or had received ≥3 prior lines of therapy incorporating an IMiD and PI. Patients received isatuximab either as monotherapy (20 mg/kg on days 1, 8, 15, and 22 [once weekly] of cycle 1 followed by 20 mg/kg on days 1 and 15 of subsequent cycles; Isa group) or in combination with dexamethasone (40 mg/d [20 mg/d in patients aged ≥75 years] once weekly; Isa-dex group). Treated patients (N = 164) had received a median of 4 (range, 2-10) prior treatment lines. Patients received a median of 5 (1-24) and 7 (1-22) treatment cycles; at data cutoff, 13 (11.9%) of 109 and 15 (27.3%) of 55 patients remained on treatment in the Isa and Isa-dex arms, respectively. Overall response rate (primary efficacy end point) was 23.9% in the Isa arm and 43.6% in the Isa-dex arm (odds ratio, 0.405; 95% confidence interval, 0.192-0.859; P = .008). Median progression-free survival and overall survival were 4.9 and 18.9 months for Isa, and 10.2 and 17.3 months for Isa-dex. Infusion reactions (mostly grade 1/2) and hematologic abnormalities were the most common adverse events. There was a similar incidence of grade 3 or higher infections in both groups (22.0% and 21.8%). In conclusion, addition of dexamethasone to isatuximab increased response rates and survival outcomes with no detrimental effect on safety. This trial was registered at www.clinicaltrials.gov as #NCT01084252.
Indexed as
Identifiers
What OpenQuestion holds
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.