Smoldering (asymptomatic) multiple myeloma MedDRA version: 14.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: BI-505
Product Code: BI-505
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Not assigned
Other descriptive name: BI-505
Concentration unit: mg/ml milligra
Sponsors
BioInvent International AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Smoldering multiple myeloma based on the International Myeloma Working Group criteria: a. Serum M-protein greater than or equal to 3 g/dl and/or bone marrow plasma cells greater than or equal to 10 percent. b. Absence of end-organ damage such as lytic bone lesions, anemia, hypercalcemia or renal failure that can be attributed to a plasma cell proliferative disorder. 2. Male or female, 18 years or older. 3. Ability to understand and willingness to sign an informed consent form. 4. Measurable disease defined by any one of the following: a. Serum monoclonal protein =1.0 g/dL. b. Serum immunoglobulin free light chain > 10 mg/dl and abnormal kappa/lambda ratio. 5. ECOG Performance status of 0-1. 6. Adequate hepatic function with aspartate transaminase and alanine transaminase =2.5 times the ULN; direct bilirubin =1.5 times the ULN. 7. Adequate renal function with calculated serum creatinine clearance =50mL/min. 8. Females of childbearing potential and males (and respective partners) must use adequate contraception during the study and at least for 12 weeks after discontinuation. Adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide, or had her last natural menstruation at least 24 months prior to baseline, or have been surgically sterilized prior to baseline, or have had a hysterectomy prior to baseline. 9. No concurrent systemic corticosteroid use within four weeks prior to screening. 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Patients with a diagnosis of symptomatic multiple myeloma or a clinical suspicion of an ongoing progression into symptomatic multiple myeloma. 2. Prior treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, biological therapies, immunomodulatory drugs, or proteasome inhibitors). 3. Use of any investigational agent within the last 3 months. 4. Current active infectious disease or positive serology for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), or Hepatitis B Surface Antigen. 5. History of allograft or solid organ transplantation. 6. Prior malignancy within 2 years, excluding smoldering multiple myeloma, adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, prostate cancer Gleason 40 yr, or any malignancy for which subject has undergone potentially curative therapy with no evidence of that disease for three years, or for which the treating physician deems the subject to be at low risk for recurrence. 7. A history of cerebrovascular disease or atrial fibrillation unless cerebrovascular disease > 2 years ago and adequately treated with statins, antihypertensive and antithrombotic therapy; or atrial fibrillation, well controlled with medication. 8. Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure > NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen-dependent COPD. 9. Clinical findings indicating cardiac or renal AL amyloidosis. 10. Evidence of significant active infection, requiring intravenous antibiotics, within 14 days before enrollment. 11. Substance abuse or other concurrent medical conditions that, in the investigator’s opinion, could confound study interpretation or affect the patient’s ability to tolerate or complete the study. 12. Significant autoimmune disease requiring systemic treatment with steroids or other immunosuppressive drugs during the last 24 months. This includes rheumatoid arthritis, systemic lupus erythematosis, inflammatory bowel disease, psoriasis, multiple sclerosis, hemolytic anemia and glomerulonephritis or other condition that has required such therapy. Mild autoimmune phenomena or inactive disease are not exclusion criteria. 13. Breast feeding women or women with a positive pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tumor response rate (defined according to the IMWG uniform response criteria);Secondary Objective: To further assess clinical safety of BI-505 To further assess the pharmacokinetic profile of BI-505 To further assess the pharmacodynamics of BI-505 To further assess the immunogenicity profile of BI-505 ;Primary end point(s): Tumor response rate according to the IMWG criteria (Complete response, Partial response, Minimal response) assessed by measurements of serum M-protein, serum free light chains, and bone marrow plasma cells ;Timepoint(s) of evaluation of this end point: At screening, on Days 1, 22, 36, 50, 64, 78, 92, 106, 120, 134 and EOS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical safety parameters (Adverse events, clinical laboratory tests, ECG and vital signs) Pharmacokinetic parameters (AUC0-168h, CL, Cmax, Ctrough, tmax, t½, Vz) Immunogenicity of BI-505 by measuring antibodies against BI-505 Pharmacodynamic parameters (including ICAM-1 saturation on bone marrow plasma cells) ;Timepoint(s) of evaluation of this end point: Adverse events: At screening, on Days 1, 8, 22, 36, 50, 64, 78, 92, 106, 120, 134 and EOS clinical laboratory tests: At screening, on Days 1, 22, 50, 92, 134 and EOS ECG: At screening and EOS vital signs: At all visits, i.e. At screening, on Days 1, 8, 22, 36, 50, 64, 78, 92, 106, 120, 134 and EOS Pharmacokinetic parameters: At Day 1 predose and +30min, Day 8 predose and +30 min, +2h and +6h, Days 22, 36, 50, 64, 78, 92, 106, 120, 134 predose and +30min and EOS Immunogenicity: At Day 1 predose and EOS Pharmacodynamic parameters: At screening, on Days 1, 22, 36, 50, 64, 78, 92, 106, 120, 134 and EOS ICAM-1 saturation on bone marrow plasma cells: At screening and on Day 50. In addition a sample will be taken to confirm response as meassured by M-component/free light chain. | — |
Countries
Sweden
Contacts
Public ContactClinical Project Manager
BioInvent International AB
Outcome results
None listed