En studie av Talquetamab med andra anticancerterapier hos deltagare med multipelt myelom (MonumenTAL-2)
En flerarmad fas 1b-studie av talquetamab med andra anticancerterapier hos deltagare med multipelt myelom
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
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Fitzroy, Australien, 3065
- St Vincents Hospital Melbourne
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Melbourne, Australien, 3004
- Alfred Health
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Southport, Australien, 4215
- Gold Coast University Hospital
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Wollongong, Australien, 2500
- Wollongong Hospital
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Brussels, Belgien, 1200
- Cliniques Universitaires St-Luc
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Edegem, Belgien, 2650
- UZA
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Ghent, Belgien, 9000
- UZ Gent
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Leuven, Belgien, 3000
- UZ Leuven
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Nantes, Frankrike, 44093
- CHU Nantes
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Pessac, Frankrike, 33604
- CHU de Bordeaux - Hospital Haut-Leveque
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Rennes, Frankrike, 35000
- Chu Rennes Hopital Pontchaillou
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Toulouse, Frankrike, 31059
- Institut Universitaire du cancer de Toulouse-Oncopole
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- University of Alabama Birmingham
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California
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San Francisco, California, Förenta staterna, 94143
- University of California San Francisco
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Colorado
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Denver, Colorado, Förenta staterna, 80218
- Colorado Blood Cancer Institute
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Emory University
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University
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New Jersey
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Hackensack, New Jersey, Förenta staterna, 07601
- Hackensack University Medical Center
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New York
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New York, New York, Förenta staterna, 10065
- Weill Cornell Medical College
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New York, New York, Förenta staterna, 10029
- Mt. Sinai School of Medicine
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28204
- Levine Cancer Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15232
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37203
- Tennessee Oncology
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Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College Of Wisconsin
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Groningen, Nederländerna, 9713 GZ
- UMCG
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Maastricht, Nederländerna, 6229 HX
- Maastricht University Medical Centre
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Utrecht, Nederländerna, 3584 CX
- UMCU
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London, Storbritannien, W1T 7HA
- University College Hospital London
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Manchester, Storbritannien, M20 4BX
- The Christie Nhs Foundation Trust
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Oxford, Storbritannien, OX3 7LE
- Churchill Hospital
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Surrey, Storbritannien, SM2 5PT
- The Royal Marsden NHS Trust Sutton
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment Regimen A: Talquetamab + Carfilzomib
Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion. |
Talquetamab will be administered subcutaneously.
Andra namn:
Carfilzomib will be administered as an IV infusion. |
|
Experimentell: Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib
Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. |
Talquetamab will be administered subcutaneously.
Andra namn:
Carfilzomib will be administered as an IV infusion. Daratumumab will be administered subcutaneously. |
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Experimentell: Treatment Regimen C: Talquetamab + Lenalidomide
Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally. |
Talquetamab will be administered subcutaneously.
Andra namn:
Lenalidomide will be self-administered orally. |
|
Experimentell: Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide
Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. |
Talquetamab will be administered subcutaneously.
Andra namn:
Daratumumab will be administered subcutaneously. Lenalidomide will be self-administered orally. |
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Experimentell: Treatment Regimen E: Talquetamab + Pomalidomide
Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally. |
Talquetamab will be administered subcutaneously.
Andra namn:
Pomalidomide will be self-administered orally. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Tidsram: Up to 1 year and 10 months
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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
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Number of Participants with AEs by Severity
Tidsram: Up to 1 year and 10 months
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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
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Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Tidsram: Up to 1 year and 6 months
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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
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Number of Participants with Dose Limiting Toxicity (DLT)
Tidsram: Up to 49 days
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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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Overall Response Rate (ORR)
Tidsram: Up to 1 year and 10 months
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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
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Very Good Partial Response (VGPR) or Better Response Rate
Tidsram: Up to 1 year and 10 months
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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
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Complete Response (CR) or Better Response Rate
Tidsram: Up to 1 year and 10 months
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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
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Stringent Complete Response (sCR)
Tidsram: Up to 1 year and 10 months
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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
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Duration of Response
Tidsram: Up to 1 year and 10 months
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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
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Time to Response
Tidsram: Up to 1 year and 10 months
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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
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Serum Concentration of Talquetamab
Tidsram: Up to 1 year and 10 months
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Serum samples will be analyzed to determine concentrations of talquetamab. |
Up to 1 year and 10 months
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Serum Concentration of Daratumumab
Tidsram: Up to 1 year and 10 months
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Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D. |
Up to 1 year and 10 months
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Number of Participants with Anti-Drug Antibodies to Talquetamab
Tidsram: Up to 1 year and 10 months
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Number of participants with anti-drug antibodies to talquetamab will be reported. |
Up to 1 year and 10 months
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Number of Participants with Anti-Drug Antibodies to Daratumumab
Tidsram: Up to 1 year and 10 months
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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
|
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Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Tidsram: Up to 1 year and 10 months
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Number of participants with anti-drug antibodies to rHuPH20 will be reported. |
Up to 1 year and 10 months
|
Samarbetspartners och utredare
Utredare
- Studierektor: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Neoplasmer
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Hematologiska sjukdomar
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Neoplasmer, Plasmacell
- Hemostatiska störningar
- Paraproteinemier
- Blodproteinstörningar
- Hemorragiska störningar
- Hemiska och lymfsjukdomar
- Multipelt myelom
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Heterocykliska föreningar, 2-ring
- Heterocykliska föreningar, smältring
- Karboxylsyror
- Piperidiner
- Ftalimider
- Ftalinsyror
- Syror, karbocyklisk
- Piperidoner
- Isoindol
- Lenalidomid
- carfilzomib
- pomalidomid
- talquetamab
Andra studie-ID-nummer
- CR108946
- 2020-004502-55 (EudraCT-nummer)
- 64407564MMY1004 (Annan identifierare: Janssen Research & Development, LLC)
- 2023-503620-60-00 (Registeridentifierare: EUCT number)
- 2023 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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