Smoldering Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.
Interventions
DRUGBI-505
Sponsors
BioInvent International AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Smoldering multiple myeloma based on the International Myeloma Working Group criteria: * Serum M-protein greater than or equal to 3 g/dL and/or bone marrow plasma cells greater than or equal to 10 percent. * 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. * Male or female, 18 years or older. * Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
Exclusion criteria
* Patients with a diagnosis of symptomatic multiple myeloma or a clinical suspicion of an ongoing progression into symptomatic multiple myeloma. * Prior or current treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, biological therapies, immunomodulatory drugs, or proteasome inhibitors), as judged by the Investigator. * Severe other conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in disease activity measured as M-protein levels in serum/urine following BI-505 treatment compared to base line according to the International Myeloma Working Group (IMWG) uniform response criteria | M-protein will be measured at screening, prior to each dose and at end of study visit, for up to 19 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The clinical safety of BI-505 will be assessed by reporting the numbers of AEs, the severity and the relationship to IMP. | At each visit and up to 28 days after the last dose. | Safety will be assessed by measuring the following clinical safety parameters; Adverse events, vital signs, clinical laboratory tests, ECG and immunogenicity. |
| The pharmacokinetic profile of BI-505 will be determined by calculating the following pharmacokinetic parameters: AUC, % AUCex, Cmax, Tmax, CL, Vss and T1/2. | Up to 28 days after the last dose. | — |
| The pharmacodynamics of BI-505 will be assessed by measuring soluble biomarkers and ICAM-1 saturation on bone marrow plasma cells. | Up to 28 days after the last dose. | — |
| The immunogenicity profile of BI-505 will be assessed by measuring antibodies towards BI-505. | Prior to first dose and at 28 days after the final dose. | — |
Countries
Sweden
Outcome results
None listed