Multiple Myeloma Clinical Trial
— MonumenTAL-2Official title:
A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
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.
| Status | Recruiting |
| Enrollment | 182 |
| Est. completion date | August 5, 2025 |
| Est. primary completion date | July 2, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | St. Vincent's Hospital Melbourne | Fitzroy | |
| Australia | Alfred Health | Melbourne | |
| Australia | Gold Coast University Hospital | Southport | |
| Australia | Wollongong Hospital | Wollongong | |
| Belgium | Cliniques Universitaires St-Luc | Brussel | |
| Belgium | UZA | Edegem | |
| Belgium | UZ Gent | Gent | |
| Belgium | UZ Leuven | Leuven | |
| France | CHU Nantes | Nantes Cedex 1 | |
| France | CHU de Bordeaux - Hospital Haut-Leveque | Pessac cedex | |
| France | Chu Rennes Hopital Pontchaillou | Rennes | |
| France | Institut Universitaire du cancer de Toulouse-Oncopole | TOULOUSE Cedex 9 | |
| Netherlands | UMCG | Groningen | |
| Netherlands | Maastricht University Medical Centre | Maastricht | |
| Netherlands | UMCU | Utrecht | |
| United Kingdom | University College Hospital London | London | |
| United Kingdom | The Christie Nhs Foundation Trust | Manchester | |
| United Kingdom | Churchill Hospital | Oxford | |
| United Kingdom | The Royal Marsden NHS Trust Sutton | Surrey | |
| United States | Emory University | Atlanta | Georgia |
| United States | University of Alabama Birmingham | Birmingham | Alabama |
| United States | Levine Cancer Institute | Charlotte | North Carolina |
| United States | Colorado Blood Cancer Institute | Denver | Colorado |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Indiana University | Indianapolis | Indiana |
| United States | Medical College Of Wisconsin | Milwaukee | Wisconsin |
| United States | Tennessee Oncology | Nashville | Tennessee |
| United States | Mt. Sinai School of Medicine | New York | New York |
| United States | Weill Cornell Medical College | New York | New York |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | University of California San Francisco | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Janssen Research & Development, LLC |
United States, Australia, Belgium, France, Netherlands, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | 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. | Up to 1 year and 10 months | |
| Primary | Number of Participants with AEs by Severity | 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. | Up to 1 year and 10 months | |
| Primary | Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters | Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported. | Up to 1 year and 6 months | |
| Primary | Number of Participants with Dose Limiting Toxicity (DLT) | 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. | Up to 49 days | |
| Secondary | Overall Response Rate (ORR) | 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. | Up to 1 year and 10 months | |
| Secondary | Very Good Partial Response (VGPR) or Better Response Rate | 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. | Up to 1 year and 10 months | |
| Secondary | Complete Response (CR) or Better Response Rate | 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. | Up to 1 year and 10 months | |
| Secondary | Stringent Complete Response (sCR) | sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria. | Up to 1 year and 10 months | |
| Secondary | Duration of Response | 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. | Up to 1 year and 10 months | |
| Secondary | Time to Response | 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. | Up to 1 year and 10 months | |
| Secondary | Serum Concentration of Talquetamab | Serum samples will be analyzed to determine concentrations of talquetamab. | Up to 1 year and 10 months | |
| Secondary | Serum Concentration of Daratumumab | Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D. | Up to 1 year and 10 months | |
| Secondary | Number of Participants with Anti-Drug Antibodies to Talquetamab | Number of participants with anti-drug antibodies to talquetamab will be reported. | Up to 1 year and 10 months | |
| Secondary | Number of Participants with Anti-Drug Antibodies to Daratumumab | Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D. | Up to 1 year and 10 months | |
| Secondary | Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) | Number of participants with anti-drug antibodies to rHuPH20 will be reported. | Up to 1 year and 10 months |
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