A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT05050097
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 166
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Regimen A: Talquetamab + Carfilzomib Carfilzomib Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion. Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib Talquetamab Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib Daratumumab SC Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide Talquetamab Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide Daratumumab SC Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide Lenalidomide Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. Treatment Regimen E: Talquetamab + Pomalidomide Talquetamab Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally. Treatment Regimen E: Talquetamab + Pomalidomide Pomalidomide Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally. Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib Carfilzomib Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. Treatment Regimen C: Talquetamab + Lenalidomide Lenalidomide Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally. Treatment Regimen A: Talquetamab + Carfilzomib Talquetamab Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion. Treatment Regimen C: Talquetamab + Lenalidomide Talquetamab Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (31)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Medical College Of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
St Vincents Hospital Melbourne
🇦🇺Fitzroy, Australia
Alfred Health
🇦🇺Melbourne, Australia
Gold Coast University Hospital
🇦🇺Southport, Australia
Cliniques Universitaires St-Luc
🇧🇪Brussel, Belgium
UZ Gent
🇧🇪Gent, Belgium
Wollongong Hospital
🇦🇺Wollongong, Australia
UZA
🇧🇪Edegem, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
CHU Nantes
🇫🇷Nantes Cedex 1, France
Chu Rennes Hopital Pontchaillou
🇫🇷Rennes, France
CHU de Bordeaux - Hospital Haut-Leveque
🇫🇷Pessac cedex, France
Maastricht University Medical Centre
🇳🇱Maastricht, Netherlands
Institut Universitaire du cancer de Toulouse-Oncopole
🇫🇷TOULOUSE Cedex 9, France
UMCG
🇳🇱Groningen, Netherlands
UMCU
🇳🇱Utrecht, Netherlands
University College Hospital London
🇬🇧London, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
The Royal Marsden NHS Trust Sutton
🇬🇧Surrey, United Kingdom
Mt. Sinai School of Medicine
🇺🇸New York, New York, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
The Christie Nhs Foundation Trust
🇬🇧Manchester, United Kingdom