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A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MonumenTAL-2)

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Talquetamab
Carfilzomib
Daratumumab SC
Lenalidomide
Pomalidomide
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama BirminghamRecruiting
  • University of California, San FranciscoRecruiting
  • Colorado Blood Cancer InstituteRecruiting
  • Emory UniversityRecruiting
  • Indiana UniversityRecruiting
  • Hackensack University Medical CenterRecruiting
  • Mt. Sinai School of MedicineRecruiting
  • Weill Cornell Medical CollegeRecruiting
  • Levine Cancer InstituteRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Sarah Cannon Research InstituteRecruiting
  • Medical College Of WisconsinRecruiting
  • St. Vincent's Hospital MelbourneRecruiting
  • Alfred HealthRecruiting
  • Gold Coast University HospitalRecruiting
  • Wollongong HospitalRecruiting
  • Cliniques Universitaires St-LucRecruiting
  • UZARecruiting
  • UZ GentRecruiting
  • UZ LeuvenRecruiting
  • CHU NantesRecruiting
  • CHU de Bordeaux - Hospital Haut-LevequeRecruiting
  • Chu Rennes - Hopital PontchaillouRecruiting
  • Institut Universitaire du cancer de Toulouse-OncopoleRecruiting
  • UMCGRecruiting
  • Maastricht University Medical CentreRecruiting
  • UMCURecruiting
  • University College Hospital LondonRecruiting
  • The Christie Nhs Foundation TrustRecruiting
  • Churchill HospitalRecruiting
  • The Royal Marsden NHS Trust SuttonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment Regimen A: Talquetamab + Carfilzomib

Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib

Treatment Regimen C: Talquetamab + Lenalidomide

Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide

Treatment Regimen E: Talquetamab + Pomalidomide

Arm Description

Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion.

Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion.

Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.

Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.

Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
Stringent Complete Response (sCR)
sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria.
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.
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.
Serum Concentration of Talquetamab
Serum samples will be analyzed to determine concentrations of talquetamab.
Serum Concentration of Daratumumab
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
Number of participants with anti-drug antibodies to talquetamab will be reported.
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.
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.

Full Information

First Posted
September 10, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05050097
Brief Title
A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Acronym
MonumenTAL-2
Official Title
A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
August 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Regimen A: Talquetamab + Carfilzomib
Arm Type
Experimental
Arm Description
Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion.
Arm Title
Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib
Arm Type
Experimental
Arm Description
Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion.
Arm Title
Treatment Regimen C: Talquetamab + Lenalidomide
Arm Type
Experimental
Arm Description
Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.
Arm Title
Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide
Arm Type
Experimental
Arm Description
Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.
Arm Title
Treatment Regimen E: Talquetamab + Pomalidomide
Arm Type
Experimental
Arm Description
Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.
Intervention Type
Drug
Intervention Name(s)
Talquetamab
Other Intervention Name(s)
JNJ-64407564
Intervention Description
Talquetamab will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Intervention Description
Carfilzomib will be administered as an IV infusion.
Intervention Type
Drug
Intervention Name(s)
Daratumumab SC
Intervention Description
Daratumumab will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide will be self-administered orally.
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Intervention Description
Pomalidomide will be self-administered orally.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Description
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.
Time Frame
Up to 1 year and 10 months
Title
Number of Participants with AEs by Severity
Description
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.
Time Frame
Up to 1 year and 10 months
Title
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Description
Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported.
Time Frame
Up to 1 year and 6 months
Title
Number of Participants with Dose Limiting Toxicity (DLT)
Description
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.
Time Frame
Up to 49 days
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
Up to 1 year and 10 months
Title
Very Good Partial Response (VGPR) or Better Response Rate
Description
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.
Time Frame
Up to 1 year and 10 months
Title
Complete Response (CR) or Better Response Rate
Description
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.
Time Frame
Up to 1 year and 10 months
Title
Stringent Complete Response (sCR)
Description
sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria.
Time Frame
Up to 1 year and 10 months
Title
Duration of Response
Description
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 Frame
Up to 1 year and 10 months
Title
Time to Response
Description
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.
Time Frame
Up to 1 year and 10 months
Title
Serum Concentration of Talquetamab
Description
Serum samples will be analyzed to determine concentrations of talquetamab.
Time Frame
Up to 1 year and 10 months
Title
Serum Concentration of Daratumumab
Description
Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D.
Time Frame
Up to 1 year and 10 months
Title
Number of Participants with Anti-Drug Antibodies to Talquetamab
Description
Number of participants with anti-drug antibodies to talquetamab will be reported.
Time Frame
Up to 1 year and 10 months
Title
Number of Participants with Anti-Drug Antibodies to Daratumumab
Description
Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D.
Time Frame
Up to 1 year and 10 months
Title
Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Description
Number of participants with anti-drug antibodies to rHuPH20 will be reported.
Time Frame
Up to 1 year and 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Mt. Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College Of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Health
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Gold Coast University Hospital
City
Southport
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Name
Wollongong Hospital
City
Wollongong
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires St-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZA
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU Nantes
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Bordeaux - Hospital Haut-Leveque
City
Pessac cedex
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Universitaire du cancer de Toulouse-Oncopole
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
UMCG
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMCU
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
University College Hospital London
City
London
ZIP/Postal Code
W1T 7HA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie Nhs Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Marsden NHS Trust Sutton
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

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