Multiple Myeloma
Conditions
Brief summary
This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma.
Detailed description
The study will have 2 parts. In the first part, different doses of SGN-CD352A will be given to different patients (each individual patient will get the same dose for all treatments). The doses will be very low at the start of the trial, and will increase only when the lower dose levels are proven safe. In the second part of the study, up to 2 dose levels that are both safe and show promising activity against MM will be given to more patients
Interventions
DRUGSGN-CD352A
On the first day of each 28-day cycle, SGN-CD352A will be given IV. The dose of SGN-CD352A is different in each cohort of the study, with the lowest dose in Cohort -1 (4 mcg/kg) and the highest in Cohort 6 (65 mcg/kg). Patients can only be enrolled into a higher dose level arm if lower doses have proven safe.
Sponsors
Seagen Inc.
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 MM requiring systemic therapy (per the International Myeloma Working Group \[IMWG\] ). * Age 18 years or older. * An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Life expectancy greater than 3 months. * Received at least 2 prior lines of therapy for MM including an immunomodulatory drug and a proteasome inhibitor. * Measurable disease, as defined by at least one of the following: Serum M protein 0.5 g/dL or higher, Urine M protein 200 mg/24 hr or higher, Serum free light chain (SFLC) 10 mg/dL or higher, and Abnormal SFLC ratio. * Adequate hematologic, renal, and hepatic function * A negative pregnancy test (for females of childbearing potential). * Patients must provide written informed consent.
Exclusion criteria
* Other invasive malignancy within the past 3 years. * Active cerebral/meningeal disease related to the underlying malignancy. * Active Grade 3 or higher infection. * Known to be positive for HIV or known to have active hepatitis B or C. * Previous allogeneic stem cell transplant. * Idiopathic interstitial pneumonia or impaired diffusion capacity of the lung for carbon monoxide (DLCO). * Cerebrovascular or cardiovascular event, or congestive heart failure within the last 6 months. * Females who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities) | Through 1 month following last dose. |
| Incidence of dose-limiting toxicity | During Cycle 1 (Trial Days 1-28) |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | Up to approximately 3 years |
| Duration of objective response | Up to approximately 3 years |
| Duration of complete response | Up to approximately 3 years |
| Complete response rate | Up to approximately 3 years |
| Incidence of antitherapeutic antibodies (ATA) | Up to approximately 3 years |
| Blood concentrations of SGN-CD352A and metabolites | Up to approximately 3 years |
| Objective response rate | Up to approximately 3 years |
| Overall survival | Up to approximately 3 years |
Other
| Measure | Time frame |
|---|---|
| Exploratory biomarkers of SGN CD352A- mediated pharmacodynamic effects | Up to approximately 3 years |
| CD352 characterization on malignant plasma cells | Up to approximately 3 years |
Countries
United States
Outcome results
None listed