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) - Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants with Relaps

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT0 个研究点目标入组 180 人开始时间: 2021年10月29日最近更新: 2022年4月4日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 180

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Participant must be 18 years of age inclusive at the time of signing the Informed Consent Form (ICF).
•2. Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (see Section 10.8).
•3. Participant has a histologically- or cytologically-confirmed diagnosis of MM as defined by IMWG criteria [Rajkumar, 2016], and
•a. Has undergone stem cell transplant or is considered transplant ineligible, and
•b. Has failed at least 3 prior lines of anti-MM therapies, including an anti-CD38 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).
•4. Participant has measurable disease with at least one of the following criteria:
•a. Serum M protein >=0.5 g/dL ( >=5 g/L), or
•b. Urine M protein >=200 mg/24h, or
•c. Serum free light chain (FLC) assay: Involved FLC level >=5 mg/dL ( >=50 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65), or
•d. Non-irradiated plasmacytoma with >=1 measurable lesion that has a single diameter of >=2 cm
•5. Participants with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met:
•a. Transplant was >100 days before study enrollment, and
•b. Participant has no active infection(s), and
•c. Participant meets the remainder of the eligibility criteria outlined in this protocol.
•6. All prior treatment-related toxicities (defined by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] Version 5.0) must be Grade =1 at the time of enrollment, except for alopecia and Grade 2 peripheral neuropathy.
•7. Life expectancy of at least 6 months, in the opinion of the investigator.
•8. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•9. Participant is capable of giving signed informed consent as described in Section 10.10 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
•10. Participant meets country-specific inclusion criteria described in Section 10.7, if applicable.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 72
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 108

排除标准

•1. Participant has symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.
•2. Participant currently has corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).
•3. Participant has evidence of active mucosal or internal bleeding.
•4. Participant has presence of an active renal condition (infection, requirement for dialysis, or any other condition that could affect participant’s safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill adequate organ function inclusion criteria (Exclusion Criteria 24).
•5. Participant has any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions (including laboratory abnormalities) that could interfere with the participant’s safety, obtaining informed consent, or compliance with the study procedures.
•6. Participant has malignancies other than the disease under study are excluded, except for any other malignancy from which the participant has been disease-free for >2 years and, in the opinion of the principal investigator and GSK medical director, 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.
•7. Participant has evidence of cardiovascular risk including any of the following criteria (please see details in protocol)
•8. Participant is a pregnant or lactating female.
•9. Participant has an active infection requiring antibiotic, antiviral, or antifungal therapy.
•10. Participant has known human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:
•a. Established anti-retroviral therapy (ART) for >=4 weeks and HIV viral load <400 copies/mL, and
•b. CD4+ T cell (CD4+) counts >=350 cells/µL, and
•c. No history of acquired immunodeficiency syndrome-defining opportunistic infections within the last 12 months.
•11. Participants with hepatitis B virus (HBV) will be excluded unless the criteria in Table 5 can be met.( please refer to the protocol section 5.2)
•12. Participants with a positive hepatitis C antibody test result or a positive hepatitis C virus (HCV) ribonucleic acid (RNA) test result at screening or =3 months before the first dose of study treatment will be excluded unless the participant can meet the following criteria:
•a. Negative HCV RNA test result
•b. Successful antiviral therapy (usually 8 weeks duration), followed by a negative HCV RNA test result after a washout period of =4 weeks.
•13. Participant has cirrhosis or current unstable liver or biliary disease per investigator assessment, defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice.
•14. Participant has alanine aminotransferase (ALT) >2.5× upper limit of normal (ULN).
•15. Participants has total bilirubin >1.5×ULN (isolated total bilirubin >1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
•For 'Other Exclusions' please refer to the protocol.

研究者

发起方

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT

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