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NCT03944057: MARCH

A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed Refractory Multiple Myeloma

Completed Phase 2 Results posted Last updated 15 June 2023
What this trial tests

Phase 2 trial testing ATG-010 in Relapse/Refractory Multiple Myeloma in 82 participants. Completed in 25 February 2022.

Timeline
2 September 2019
Primary endpoint
25 February 2022
25 February 2022

Quick facts

Lead sponsorAntengene Corporation
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment82
Start date2 September 2019
Primary completion25 February 2022
Estimated completion25 February 2022
Sites17 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Antengene Corporation — full company profile →

Who can join

18 and older, any sex, with Relapse/Refractory Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate (ORR) Primary · 12 months

The primary efficacy endpoint of ORR consists of proportion of patients who achieve PR, VGPR, CR, or sCR according to IMWG 2016 criteria: * CR means Negative IFE of serum and urine, disappearance of any soft tissue plasmacytomas (SPD), and \<5% plasma cells in bone marrow aspirates; * sCR means CR as defined above plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (κ/λ ratio ≤ 4:1 or ≥ 1:2 for κ and λ patients, respectively, after counting ≥ 100 plasma cells); * VGPR means Serum and urine M-protein detectable by IFE but not on electrophoresis, or ≥

GroupValue95% CI
ATG-010 + Dexamethasone24
Progression-Free Survival (PFS) Secondary · 12 months

To evaluate progression-free survival

GroupValue95% CI
ATG-010 + Dexamethasone3.72.02 – 4.66

Adverse events — posted to ClinicalTrials.gov

Time frame: From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ATG-010 + Dexamethasone
Serious: 45/82 (55%)
Deaths: 7/82

Serious adverse events (10 terms)

ReactionSystemATG-010 + Dexamethasone
PeumoniaInfections and infestations
Platelet count dicreasedInvestigations
Upper respiratory infectionInfections and infestations
AnemiaBlood and lymphatic system disorders
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
White blood cell count decreasedInvestigations
Neutrophil count decreasedInvestigations
HyponatremiaMetabolism and nutrition disorders
HypokalemiaMetabolism and nutrition disorders
VomitingGastrointestinal disorders
Other adverse events (58 terms — click to expand)

ReactionSystemATG-010 + Dexamethasone
Decreased platelet countInvestigations
AnemiaBlood and lymphatic system disorders
Decreased white-cell countInvestigations
NauseaGastrointestinal disorders
Lymphocyte count decreasedInvestigations
Neutrophil count decreasedInvestigations
HyponatremiaMetabolism and nutrition disorders
Weight lossInvestigations
Decreased appetiteMetabolism and nutrition disorders
AdynamiaGeneral disorders
HyperglycemiaMetabolism and nutrition disorders
VomitingGastrointestinal disorders
HypocalcemiaMetabolism and nutrition disorders
HypokalaemiaMetabolism and nutrition disorders
HypoalbuminaemiaMetabolism and nutrition disorders
DiarrheaGastrointestinal disorders
Lung infectionInfections and infestations
Aspartate aminotransferase increasedInvestigations
Alanine aminotransferase increasedInvestigations
HypophosphatemiaMetabolism and nutrition disorders
Infection upper respiratoryInfections and infestations
SleeplessnessPsychiatric disorders
Blood lactate dehydrogenase increasedInvestigations
HyperuricemiaMetabolism and nutrition disorders
γ-glutamyltransferase increasedInvestigations
DizzyNervous system disorders
ConstipationGastrointestinal disorders
HypertriglyceridemiaMetabolism and nutrition disorders
FatigueGeneral disorders
Serum creatinine increasedInvestigations
C-reactive protein increasedInvestigations
CoughRespiratory, thoracic and mediastinal disorders
Vision blurredEye disorders
Total protein decreasedInvestigations
HypochloridemiaMetabolism and nutrition disorders
Oedema peripheralGeneral disorders
Tachycardia sinusCardiac disorders
Blood Urea increasedInvestigations
Blood bilirubin increasedInvestigations
FeverGeneral disorders

Most-reported serious reactions: Peumonia, Platelet count dicreased, Upper respiratory infection, Anemia, Pulmonary embolism, White blood cell count decreased, Neutrophil count decreased, Hyponatremia.

Data from ClinicalTrials.gov NCT03944057 adverse events section.

Sponsor's own description

This is an open-label, single-arm study of ATG-010 (selinexor) plus low-dose Dexamethasone (Sd) in patients with multiple myeloma previously treated with lenalidomide and bortezomib refractory to prior treatment with immunomodulatory agents and proteasome Inhibitors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Selinexor plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma previously treated with an immunomodulatory agent and a proteasome inhibitor (MARCH): a phase II, single-arm study.
    Qiu L, Xia Z, Fu C, Chen W, et al · · 2022 · cited 23× · PMID 35379237 · DOI 10.1186/s12916-022-02305-4
  2. Targeting Nuclear Export Proteins in Multiple Myeloma Therapy.
    Theodoropoulos N, Lancman G, Chari A. · · 2020 · cited 16× · PMID 33074469 · DOI 10.1007/s11523-020-00758-2
  3. Recent Advances in the Applications of Small Molecules in the Treatment of Multiple Myeloma.
    Abramson HN. · · 2023 · cited 12× · PMID 36768967 · DOI 10.3390/ijms24032645
  4. The Role of Belantamab Mafodotin, Selinexor, and Melflufen in Multiple Myeloma.
    McCurdy A, Visram A. · · 2022 · cited 8× · PMID 36417082 · DOI 10.1007/s11899-022-00682-4
  5. Profile and Management of Toxicity of Selinexor and Belantamab Mafodotin for the Treatment of Triple Class Refractory Multiple Myeloma.
    Neupane K, Wahab A, Masood A, Faraz T, et al · · 2021 · cited 7× · PMID 34234609 · DOI 10.2147/jbm.s317966
  6. Treatment of multiple myeloma with selinexor: a review.
    Huang Q, Zhao R, Xu L, Hao X, et al · · 2024 · cited 4× · PMID 38186637 · DOI 10.1177/20406207231219442
  7. Mechanistic Insights and Therapeutic Potentials of Ubiquitin-Proteasome System in Non-Small Cell Lung Cancer.
    Zhou G, Tan J, Zhang P, Zhou Z, et al · · 2025 · cited 3× · PMID 40313038 · DOI 10.1111/cpr.70050
  8. Novel Approaches Outside the Setting of Immunotherapy for the Treatment of Multiple Myeloma: The Case of Melflufen, Venetoclax, and Selinexor.
    Sgherza N, Curci P, Rizzi R, Musto P. · · 2021 · cited 2× · PMID 34660279 · DOI 10.3389/fonc.2021.716751

Verify or expand the search:

Other trials of ATG-010

Trials testing the same drug.

Other recruiting trials for Relapse/Refractory Multiple Myeloma

Currently open trials in the same condition.

Other Antengene Corporation trials

Trials by the same sponsor.

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