Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants with Relapsed or Refractory Multiple Myeloma (DREAMM14)
- Conditions
- Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-508213-16-00
- Lead Sponsor
- Glaxosmithkline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 180
Participant must be 18 years of age inclusive at the time of signing the Informed Consent Form (ICF)., Participant meets country-specific inclusion criteria described in Section 10.7, if applicable., Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2., Participant has a histologically- or cytologically-confirmed diagnosis of myeloma 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)., 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)., 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 protocol. , 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. , Life expectancy of at least 6 months, in the opinion of the investigator., Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Female Participants A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions apply: • Is not a woman of childbearing potential (WOCBP) as defined in Section 10.9, or • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency (as described in Section 10.9) during the treatment period and for at least 4 months after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose (Cycle 1 Day 1) of study treatment (see Section 8.2.7). Additional requirements for pregnancy testing during and after study treatment are provided in Section 8.2.7 and the Schedule of Activities (SoA) (Section 1.3). The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. b.Male Participants Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following conditions from the time of first dose of study treatment until 6 months after the las
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., 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., Participants with hepatitis B virus (HBV) will be excluded unless the criteria in Table 5 can be met. (refer to the protocol section 5.2), 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., 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., Participant has alanine aminotransferase (ALT) >2.5× upper limit of normal (ULN)., Participants has total bilirubin >1.5×ULN (isolated total bilirubin >1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%), Participant has received systemic anti-myeloma therapy within =14 days or 5 half lives, whichever is shorter, before the first dose of study treatment., Participant has received plasmapheresis ?7 days before the first dose of study treatment., Participant has received systemic therapy with high dose steroids (equivalent to =60 mg prednisone daily for =4 days) administered to treat MM or non MM disease within =14 days before the first dose of study treatment., Participant has received a prior allogenic stem cell transplant., Participant currently has corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK)., Participant has used an investigational drug =14 days or 5 half lives, whichever is shorter, before the first dose of study treatment or has received therapy with a monoclonal antibody =30 days before the first dose of study treatment, whichever is shorter. Note: Use of monoclonal antibodies for serious conditions unrelated to multiple myeloma, such as COVID, may be permitted after consultation with the GSK Medical Director., Participant has evidence of active mucosal or internal bleeding., 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 in protocol)., 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., Participant has malignancies other than the disease under study are excluded, except for any other ma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method