Relapsed/ Refractory Multiple Myeloma
Conditions
Brief summary
The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.
Interventions
DRUGTalquetamab
Talquetamab will be administered as a subcutaneous (SC) injection.
DRUGTeclistamab
Teclistamab will be administered as a SC injection.
DRUGPD-1 Inhibitor
The PD-1 inhibitor will be administered as an intravenous injection.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
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 * Participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit * Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL); b) Urine M-protein level \>= 200 milligrams (mg) per 24 hours; c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>= 10 milligrams/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
Exclusion criteria
* Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor \[PI\] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months) * Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ transplant * Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis * 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 * Live, attenuated vaccine within 4 weeks before the first dose of study treatment * Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\<=) 1 (except alopecia \[any grade\] or peripheral neuropathy to Grade \<= 2) * Received a cumulative dose of corticosteroids equivalent to \>= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to 2 years 5 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 Adverse Events (AEs) by Severity | Up to 2 years 5 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. 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 adverse event. |
| Number of Participants with Abnormalities in Clinical Laboratory Assessments | Up to 2 years 5 months | Number of participants with abnormalities in clinical laboratory assessments (serum chemistry and hematology) will be reported. |
| Number of Participants with Dose-Limiting Toxicity (DLTs) | Up to 2 years 5 months | The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to 2 years 5 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. |
| Very Good Partial Response (VGPR) or Better Response Rate | Up to 2 years 5 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 2 years 5 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) Rate | Up to 2 years 5 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 2 years 5 months | Duration of response is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 criteria or death due to any cause, whichever occurs first. |
| Time to Response | Up to 2 years 5 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 Concentrations of Talquetamab | Up to 2 years 5 months | Serum samples will be analyzed to determine concentrations of Talquetamab using validated, specific, and sensitive immunoassay methods. |
| Serum Concentrations of Teclistamab | Up to 2 years 5 months | Serum samples will be analyzed to determine concentrations of Teclistamab using validated, specific, and sensitive immunoassay methods. |
| Serum Concentrations of PD-1 Inhibitor | Up to 2 years 5 months | Serum samples will be analyzed to determine concentrations of PD-1 inhibitor using validated, specific, and sensitive immunoassay methods. |
| Number of Participants with Anti-Talquetamab Antibodies | Up to 2 years 5 months | Number of participants with anti-talquetamab antibodies will be reported. |
| Number of Participants with Anti-Teclistamab Antibodies | Up to 2 years 5 months | Number of participants with anti-teclistamab antibodies will be reported. |
| Number of Participants with Anti-PD-1 Inhibitor Antibodies | Up to 2 years 5 months | Number of participants with anti-PD-1 inhibitor antibodies will be reported. |
Countries
France, Germany, Spain, United States
Contacts
STUDY_DIRECTORJanssen Research and Development, LLC Clinical Trial
Janssen Research and Development LLC
Outcome results
None listed