A Study to Investigate the Efficacy of Venetoclax Plus Lenalidomide and Dexamethasone in Participants with Newly Diagnosed t(11;14)-Positive Multiple Myeloma
- Conditions
- Multiple MyelomaMedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-003287-31-ES
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
- Subject must have documented, confirmed active MM with = 10% clonal bone marrow plasma cells or biopsy-proven bone or extramedullary plasmacytoma and any one or more of the following myeloma-defining events:
• Evidence of end organ damage attributed to the underlying plasma cell proliferative disorder and satisfying at least one of the CRAB criteria:
1. Hypercalcemia (serum calcium > 0.25 mmol/L [> 1 mg/dL] higher than the upper limit of normal (ULN) or > 2.75 mmol/L [> 11 mg/dL]);
2. Renal insufficiency (creatinine clearance [CrCL] < 40 mL/min or serum creatinine > 177 µmol/L [> 2 mg/dL]);
3. Anemia (hemoglobin > 20 g/L below the lower limit of normal or hemoglobin < 100 g/L);
4. Bone lesions (one or more osteolytic lesions on skeletal radiography, computed tomography [CT], or positive emission tomography [PET]-CT).
• Or Any one or more of the following biomarkers of malignancy:
1. = 60% clonal bone marrow plasma cells;
2. Involved:uninvolved serum free light chain ratio = 100;
3. > 1 focal lesions on magnetic resonance imaging (MRI; each focal lesion must be 5 mm or more in size).
- Subject must have measurable disease defined by at least one of the following criteria:
• Serum M-protein = 1.0 g/dL (immunoglobulin [Ig]G myeloma) or = 0.5 g/dL (IgA, IgM, IgD, or IgE myeloma);
• Urine M-protein = 200 mg/24 hours;
• Serum free light chain (FLC) = 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal.
- Subject is newly diagnosed and not considered a candidate for high-dose therapy and hematopoietic stem cell transplantation (HSCT) due to:
• Age = 65 years;
• Or age less than (<) 65 years with presence of comorbid condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with hematopoietic stem cell transplantation. Sponsor review and approval of participants below 65 years of age is required.
- Subject must have MM positive for the t(11;14) translocation, as determined by an analytically validated fluorescence in situ hybridization (FISH) assay per central laboratory testing of a bone marrow aspirate sample (enrollment with local t(11;14)-positive FISH results will be considered at the discretion of the therapeutic area medical director or scientific director).
- Subject must have Eastern Cooperative Oncology Group performance status = 2.
- Subject must have laboratory values meeting the following criteria within the screening period before the first dose of study drug:
• Absolute neutrophil count (ANC) = 1000/µL; subject may use growth factor support to achieve ANC eligibility criteria;
• Platelets: = 75,000/mm3. For subjects with > 50% myeloma involvement in the marrow, a platelet count of = 50,000 mm3 is allowed. Subjects may not have received a platelet transfusion within 72 hours prior to the platelet count used
for eligibility;
• Hemoglobin = 8.0 g/dL; subject may receive red blood cell transfusions in accordance with institutional guidelines to meet this criteria;
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 × upper limit of normal (ULN);
• Total bilirubin = 1
• The subject is not naïve to treatment with venetoclax or another BCL-2 inhibitor
• The subject has been treated or received any of the following:
o Prior or current systemic therapy or HSCT for MM
o Radiation therapy within 2 weeks of dosing
o Plasmapheresis within 4 weeks of dosing
o Immunization with live vaccine within 8 weeks of dosing
• The subject has a history of other active malignancies, including myelodysplastic syndromes (MDS) within the past three years except adequately treated in situ carcinoma of the cervix, uteri or the breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; Prostate cancer Gleason grade 6 or lower AND with stable prostate specific antigen levels off treatment; previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.
• The subject has known allergies, hypersensitivities, or intolerance to any of the study drug or excipients.
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