Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM 14)
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- Titre complet:
- A Phase 2, Randomized, Parallel, Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-agent Belantamab Mafodotin (GSK2857916) in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM-14)
- Stade ou Condition:
- Multiple Myeloma
- Phase d'étude:
- Phase 2
- Résumé:
- This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.
- Description détaillée:
- Non disponible
- Traitements:
- Drug : Belantamab mafodotin
Belantamab mafodotin will be administered.
- Groupes d'étude:
- Experimental : Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1
- Experimental : Cohort 2: Participants receiving belantamab mafodotin at DL 2
- Experimental : Cohort 3: Participants receiving belantamab mafodotin at DL 3
- Experimental : Cohort 4: Participants receiving belantamab mafodotin at DL 4
- Experimental : Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification
- Type d'étude:
- Interventional
- Protocole de l'étude:
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Intervention Model Description: Belantamab mafodotin will be administered using various dosing regimens.
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Masking Description: It is an open label study
- Statut du recrutement:
- En cours
- Critères d'admissibilités:
-
Inclusion Criteria:
- Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).
- France specific: participants have failed at least 4 prior lines of anti-myeloma therapies
- Participant has measurable disease per modified IMWG criteria.
- Life expectancy of at least 6 months, in the opinion of the investigator.
- Male and female participants agree to abide by protocol-defined contraceptive requirements.
- Participant is capable of giving signed informed consent.
- Participant meets country-specific inclusion criteria described in the protocol.
- Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.
- Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).
- Evidence of active mucosal or internal bleeding.
- Presence of an active renal condition.
- Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures.
- Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for >2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
- Evidence of cardiovascular risk as per the protocol criteria.
- Pregnant or lactating female.
- Active infection requiring antibiotic, antiviral, or antifungal treatment.
- Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met.
- Hepatitis B and C will be excluded unless the criteria in protocol can be met.
- Cirrhosis or current unstable liver or biliary disease.
- Alanine aminotransferase (ALT) >2.5× upper limit of normal (ULN).
- Total Bilirubin >1.5×ULN.
- Systemic anti-MM therapy within <=14 days or 5 half-lives, whichever is shorter.
- Systemic therapy with high dose steroids within <=14 days before the first dose of study treatment.
- Prior allogenic stem cell transplant.
- Prior treatment with a monoclonal antibody <=30 days before the first dose of study treatment. Use of monoclonal antibodies for serious conditions unrelated to multiple myeloma, such as COVID, may be permitted.
- Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy or hypersensitivity reactions to any components of the study treatment.
- Treatment with an antibody-drug conjugate.
- Participant has received any major surgery <=4 weeks before the first dose of study treatment. An exception may be allowed for bone stabilizing surgery.
- Inadequate bone marrow reserve or organ functions as demonstrated by any of the following: a. Absolute neutrophil count <1.0×10^9/L, b. Hemoglobin <8 gram/deciliter (g/dL), c. Platelet count <50×10^9/L, d. Spot urine (albumin/creatinine ratio) >500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 meter square (mL/min/1.73m^2).
- UK specific: a. Absolute neutrophil count <1.5×10^9/L, c. Platelet count <75×10^9/L
- Lieux / Centres:
-
GSK Investigational Site, Oshawa, Ontario – En cours
GSK Investigational Site, Toronto, Ontario – En cours
GSK Investigational Site, Montreal, Quebec – En cours
GSK Investigational Site, Montréal, Quebec – En cours
- Contacts:
- Name: US GSK Clinical Trials Call Center
Phone: 877-379-3718
Email: [email protected]
- Publications:
- ???
- Date d’affichage:
- 2021-10-01
- Date de début:
- March 3, 2022
- Dernière mise à jour:
- 2023-04-10
- Nombre d'inscriptions anticipées:
- 180
- Date de fin prévue:
- 2024-09-06
- Date de fin prévue de l'étude primaire:
- 2024-05-13
- Condition:
- Multiple Myeloma
- Genre:
- All
- Âge:
- 18 Years-N/A
- Accepte des bénévoles en santé:
- No
- Pays participants:
- Argentina
- Australia
- Brazil
- Canada
- France
- Germany
- Greece
- India
- Ireland
- Italy
- Korea, Republic of
- Mexico
- Poland
- Spain
- Switzerland
- Taiwan
- Thailand
- United Kingdom
- United States
- Numéro d’identification:
- NCT05064358
- Autres numéros d'identification de l'étude:
- 209628
- Comité de suivi des données:
- Yes
- Produit réglementé par la FDA (É-U):
- Yes
- IPD Sharing Statement :
- ???
- Responsables de l’étude:
-
Sponsor
- Commanditaires de l’étude:
- lead_sponsor
GlaxoSmithKline
Industry
- Collaborators:
- ???
- Chercheurs:
- GSK Clinical Trials GlaxoSmithKline
- Protocol Registration and Results System:
- ???
- Date de vérification:
- 2023-04-01