Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2022-001942-39-GR
EUCTR2022-001942-39-GR
Active, not recruiting
Phase 1

A phase 1/2, dose and schedule evaluation study to investigate the safety and clinical activity of belantamab mafodotin administered in combination with lenalidomide, dexamethasone and nirogacestat in patients with transplant ineligible newly diagnosed multiple myeloma

Hellenic Society of Hematology (EAE)0 sites36 target enrollmentSeptember 19, 2022
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionsewly diagnosed patients with multiple myelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsBlenrep

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
ewly diagnosed patients with multiple myeloma
Sponsor
Hellenic Society of Hematology (EAE)
Enrollment
36
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 19, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Hellenic Society of Hematology (EAE)

Eligibility Criteria

Inclusion Criteria

  • •1\. Participants \>18 of age.
  • •2\. Monoclonal plasma cells in BM \=10% or presence of biopsy proven plasmacytoma and documented MM satisfying \=1 of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy criteria:
  • •CRAB criteria:
  • •i. Hypercalcemia: serum calcium \>0\.25 mmol/L higher than ULN or \>2\.75 mmol/L.
  • •ii. Renal insufficiency: CrCl \<40mL/min or serum creatinine \>177 µmol/L.
  • •iii. Anemia: hemoglobin \>2 g/dL below the LLN or hemoglobin \<10 g/dL.
  • •iv. Bone lesions: \=1 osteolytic lesions on skeletal radiography, CT, or PET\-CT.
  • •Biomarkers of Malignancy:
  • •a. Clonal BM plasma cell percentage \=60%.
  • •b. Involved:uninvolved sFLC ratio \=100\.

Exclusion Criteria

  • •1\. Prior systemic therapy for MM/SMM.
  • •o NOTE 1: An emergency course of steroids permitted.
  • •o NOTE 2: Focal palliative radiation permitted prior to enrollment, provided occurred \=2 weeks before first drug, participant has recovered from radiation\-related toxicities, and participant did not require corticosteroid administration for radiation\-induced AEs.
  • •2\. Peripheral neuropathy or neuropathic pain \=Grade 2, as defined by NCI\-CTCAE V.5\.
  • •3\. Major surgery within 4 weeks before first dose.
  • •o NOTE 1: Patients who underwent major surgery must be clinically stable to be enrolled.
  • •o NOTE 2: Major surgery shall be defined based on Investigator’s judgment.
  • •4\. Presence of active renal condition. Participants with isolated proteinuria resulting from MM are eligible, provided they meet other inclusion criteria.
  • •5\. Any serious and/or unstable pre\-existing medical or psychiatric disorder, or other conditions that could interfere with participant’s safety, obtaining informed consent, or compliance to procedures.
  • •6\. Evidence of active mucosal or internal bleeding uncontrolled by local therapy and not explained by reversible coagulopathy.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Belantamab Mafodotin in combination with Lenalidomide and Dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who transplant ineligible.
EUCTR2020-005826-27-GRHellenic Society of Hematology (EAE)66
Active, not recruiting
Phase 1
Belantamab Mafodotin in combination with Daratumumab, Lenalidomide and Dexamethasone for the treatment of patients with newly diagnosed multiple myeloma transplant ineligible.newly diagnosed multiple myelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2021-006792-42-GRHellenic Society of Hematology (EAE)36
Active, not recruiting
Phase 1
A PHASE 1/2, DOSE AND SCHEDULE EVALUATION STUDY TO INVESTIGATE THE SAFETY AND CLINICAL ACTIVITY OF BELANTAMAB MAFODOTIN ADMINISTERED IN COMBINATION WITH POMALIDOMIDE AND DEXAMETHASONE WITH OR WITHOUT DARATUMUMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA PREVIOUSLY TREATED WITH ONE TO THREE LINES OF THERAPY WHO ARE LENALIDOMIDE REFRACTORYRelapsed/refractory multiple myelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2022-001941-19-GRHellenic Society of Hematology (EAE)60
Not yet recruiting
Phase 1
DREAMM-9: Phase 1 Study of Belantamab Mafodotin Plus Standard of care in NewlyDiagnosed Multiple Myeloma patientsHealth Condition 1: C900- Multiple myeloma
CTRI/2024/03/064587GlaxoSmithKline Research Development Limited
Active, not recruiting
Phase 1
A phase 1/2 study in which, DTX-SPL8783, the trial medication will beadministered (alone or in combination with nintedanib) in order to assess the safety, tolerability, pharmacokinetics (distribution of DTX-SPL8783 in the body) and efficacy in patients with advanced malignant tumours.ocally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC).MedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2016-000877-19-GBStarpharma Pty Ltd.65