Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
Interventions
DRUGTalquetamab
Talquetamab will be administered subcutaneously.
DRUGCarfilzomib
Carfilzomib will be administered as an IV infusion.
DRUGDaratumumab SC
Daratumumab will be administered subcutaneously.
DRUGLenalidomide
Lenalidomide will be self-administered orally.
DRUGPomalidomide
Pomalidomide will be self-administered orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria * Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level \>= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration * A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration * Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program
Exclusion criteria
* Live, attenuated vaccine within 4 weeks before the first dose of study treatment * Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within the 14-day period before the start of study treatment administration * Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required * Known to be seropositive for human immunodeficiency virus * History of stroke or seizure within 6 months prior to the first dose of study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | Up to 1 year and 10 months | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
| Number of Participants with AEs by Severity | Up to 1 year and 10 months | Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE. |
| Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters | Up to 1 year and 6 months | Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported. |
| Number of Participants with Dose Limiting Toxicity (DLT) | Up to 49 days | Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to 1 year and 10 months | ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Response to treatment will be evaluated by the investigator based on IMWG criteria. |
| Very Good Partial Response (VGPR) or Better Response Rate | Up to 1 year and 10 months | VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response \[sCR\] + complete response \[CR\] +VGPR) according to the IMWG 2016 criteria. |
| Complete Response (CR) or Better Response Rate | Up to 1 year and 10 months | CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria. |
| Stringent Complete Response (sCR) | Up to 1 year and 10 months | sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria. |
| Duration of Response | Up to 1 year and 10 months | Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG 2016 criteria, or death due to disease progression, whichever occurs first. |
| Time to Response | Up to 1 year and 10 months | Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better. |
| Serum Concentration of Talquetamab | Up to 1 year and 10 months | Serum samples will be analyzed to determine concentrations of talquetamab. |
| Serum Concentration of Daratumumab | Up to 1 year and 10 months | Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D. |
| Number of Participants with Anti-Drug Antibodies to Talquetamab | Up to 1 year and 10 months | Number of participants with anti-drug antibodies to talquetamab will be reported. |
| Number of Participants with Anti-Drug Antibodies to Daratumumab | Up to 1 year and 10 months | Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D. |
| Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) | Up to 1 year and 10 months | Number of participants with anti-drug antibodies to rHuPH20 will be reported. |
Countries
Australia, Belgium, France, Netherlands, United Kingdom, United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed