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A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2)

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Teclistamab
Daratumumab
Pomalidomide
Lenalidomide
Bortezomib
Nirogacestat
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
  • Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab [tec]-daratumumab [dara]-pomalidomide [pom]) only: Participant has relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide [len]-bortezomib [bor]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat [niro]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb); Treatment Regimen D (tec-len) only: Participant has multiple myeloma and has received greater than or equal to (>=) 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if previously treated has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly diagnosed multiple myeloma
  • Have measurable disease at screening as defined by at least one of the following: serum M-protein level >= 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
  • A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [hCG]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration and must agree to further serum or urine pregnancy tests during the study
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 100 days after the last dose of study treatment

Exclusion Criteria:

  • Prior treatment with any therapy that targets B-cell maturation antigen (BCMA): This exclusion does not apply to Treatment Regimen C
  • Live, attenuated vaccine within 30 days 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

Sites / Locations

  • University of Alabama at Birmingham
  • University of California, San Francisco
  • Colorado Blood Cancer Institute
  • Emory University
  • Indiana University Melvin and Bren Simon Cancer Center
  • Washington University School of Medicine
  • Hackensack University Medical Center
  • Memorial Sloan-Kettering Cancer Center
  • Weill Cornell Medical College
  • Levine Cancer Institute
  • University of Pittsburgh Medical Center
  • Sarah Cannon Research Institute
  • Seattle Cancer Care Alliance
  • Medical College Of Wisconsin
  • St. Vincent's Hospital Melbourne
  • Alfred Health
  • Calvary Mater Newcastle Hospital
  • UZA
  • UZ Gent
  • Centre Leon Bérard
  • CHU Nantes
  • CHU de Bordeaux - Hospital Haut-Leveque
  • Chu Rennes - Hopital Pontchaillou
  • Institut Universitaire du cancer de Toulouse-Oncopole
  • University College Hospital
  • The Christie Nhs Foundation Trust
  • The Royal Marsden NHS Trust Sutton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide

Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)

Treatment Regimen C: Teclistamab + Nirogacestat

Treatment Regimen D: Teclistamab + Lenalidomide

Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide

Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)

Arm Description

Participants will receive teclistamab plus daratumumab plus pomalidomide.

Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.

Participants will receive teclistamab plus nirogacestat.

Participants will receive teclistamab plus lenalidomide.

Participants will receive teclistamab plus daratumumab plus lenalidomide.

Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.

Outcomes

Primary Outcome Measures

Number of Participants with Incidence of Adverse Events (AEs)
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Number of Participants with AEs by Severity
Number of participants with AEs by severity will be reported.
Number of Participants with Abnormalities in Laboratory Values
Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
Number of Participants with Dose-Limiting Toxicity (DLT)
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.

Secondary Outcome Measures

Overall Response Rate (ORR)
ORR is defined as the proportion 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
VGPR or better response rate is defined as the proportion 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 proportion of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
Stringent Complete Response (sCR) Rate
sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria.
Duration of Response
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 criteria.
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 Concentrations of Teclistamab
Serum concentrations of teclistamab will be reported.
Serum Concentrations of Daratumumab
Serum concentrations of daratumumab will be reported.
Serum Concentrations of Nirogacestat
Serum concentration of nirogacestat will be reported.
Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab
Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens.
Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab
Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A, B, E and F.
Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A, B, E and F.

Full Information

First Posted
January 20, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04722146
Brief Title
A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Acronym
MajesTEC-2
Official Title
A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
February 24, 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 teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab 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
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
Arm Type
Experimental
Arm Description
Participants will receive teclistamab plus daratumumab plus pomalidomide.
Arm Title
Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)
Arm Type
Experimental
Arm Description
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.
Arm Title
Treatment Regimen C: Teclistamab + Nirogacestat
Arm Type
Experimental
Arm Description
Participants will receive teclistamab plus nirogacestat.
Arm Title
Treatment Regimen D: Teclistamab + Lenalidomide
Arm Type
Experimental
Arm Description
Participants will receive teclistamab plus lenalidomide.
Arm Title
Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide
Arm Type
Experimental
Arm Description
Participants will receive teclistamab plus daratumumab plus lenalidomide.
Arm Title
Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)
Arm Type
Experimental
Arm Description
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.
Intervention Type
Drug
Intervention Name(s)
Teclistamab
Other Intervention Name(s)
JNJ-64007957
Intervention Description
Participants will receive teclistamab.
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Description
Participants will receive daratumumab.
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Intervention Description
Participants will receive pomalidomide.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Participants will receive lenalidomide.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Participants will receive bortezomib.
Intervention Type
Drug
Intervention Name(s)
Nirogacestat
Intervention Description
Participants will receive nirogacestat.
Primary Outcome Measure Information:
Title
Number of Participants with Incidence of Adverse Events (AEs)
Description
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Time Frame
Up to 2 year and 5 months
Title
Number of Participants with AEs by Severity
Description
Number of participants with AEs by severity will be reported.
Time Frame
Up to 2 year and 5 months
Title
Number of Participants with Abnormalities in Laboratory Values
Description
Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
Time Frame
Up to 2 year and 5 months
Title
Number of Participants with Dose-Limiting Toxicity (DLT)
Description
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
Time Frame
Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B)
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR is defined as the proportion of participants who achieve partial response (PR) or better according to the international myeloma working group (IMWG) 2016 criteria.
Time Frame
Up to 2 year and 5 months
Title
Very Good Partial Response (VGPR) or Better Response Rate
Description
VGPR or better response rate is defined as the proportion 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 2 year and 5 months
Title
Complete Response (CR) or Better Response Rate
Description
CR or better response rate is defined as the proportion of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
Time Frame
Up to 2 year and 5 months
Title
Stringent Complete Response (sCR) Rate
Description
sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria.
Time Frame
Up to 2 year and 5 months
Title
Duration of Response
Description
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 criteria.
Time Frame
Up to 2 year and 5 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 2 year and 5 months
Title
Serum Concentrations of Teclistamab
Description
Serum concentrations of teclistamab will be reported.
Time Frame
Up to 2 year and 5 months
Title
Serum Concentrations of Daratumumab
Description
Serum concentrations of daratumumab will be reported.
Time Frame
Up to 2 year and 5 months
Title
Serum Concentrations of Nirogacestat
Description
Serum concentration of nirogacestat will be reported.
Time Frame
Up to 2 year and 5 months
Title
Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab
Description
Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens.
Time Frame
Up to 2 year and 5 months
Title
Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab
Description
Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A, B, E and F.
Time Frame
Up to 2 year and 5 months
Title
Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Description
Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A, B, E and F.
Time Frame
Up to 2 year and 5 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 Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab [tec]-daratumumab [dara]-pomalidomide [pom]) only: Participant has relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide [len]-bortezomib [bor]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat [niro]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb); Treatment Regimen D (tec-len) only: Participant has multiple myeloma and has received greater than or equal to (>=) 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if previously treated has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly diagnosed multiple myeloma Have measurable disease at screening as defined by at least one of the following: serum M-protein level >= 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [hCG]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration and must agree to further serum or urine pregnancy tests during the study A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 100 days after the last dose of study treatment Exclusion Criteria: Prior treatment with any therapy that targets B-cell maturation antigen (BCMA): This exclusion does not apply to Treatment Regimen C Live, attenuated vaccine within 30 days 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research and Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research and Development LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1032
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical College Of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Alfred Health
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Calvary Mater Newcastle Hospital
City
Waratah
ZIP/Postal Code
2298
Country
Australia
Facility Name
UZA
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Centre Leon Bérard
City
Lyon Cedex 8
ZIP/Postal Code
69373
Country
France
Facility Name
CHU Nantes
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Bordeaux - Hospital Haut-Leveque
City
Pessac cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Chu Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Institut Universitaire du cancer de Toulouse-Oncopole
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
The Christie Nhs Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
The Royal Marsden NHS Trust Sutton
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & 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 Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

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