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

Multiple Myeloma Clinical Trial

— MajesTEC-2  

Official title:

A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04722146
• Other study ID #: CR108927
• Secondary ID: 2020-004404-3364
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 12, 2021
• Est. completion date: February 24, 2025

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: February 24, 2025
• Est. primary completion date: October 31, 2024
• 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

• 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Teclistamab
Participants will receive teclistamab.
• Daratumumab
Participants will receive daratumumab.
• Pomalidomide
Participants will receive pomalidomide.
• Lenalidomide
Participants will receive lenalidomide.
• Bortezomib
Participants will receive bortezomib.
• Nirogacestat
Participants will receive nirogacestat.

Locations

Country	Name	City	State
Australia	St Vincents Hospital Melbourne	Fitzroy
Australia	Alfred Health	Melbourne
Australia	Calvary Mater Newcastle Hospital	Waratah
Belgium	UZA	Edegem
Belgium	UZ Gent	Gent
France	Centre Leon Berard	Lyon Cedex 8
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
United Kingdom	University College Hospital	London
United Kingdom	The Christie Nhs Foundation Trust	Manchester
United Kingdom	The Royal Marsden NHS Trust Sutton	Surrey
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at 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 Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Medical College Of Wisconsin	Milwaukee	Wisconsin
United States	Tennessee Oncology	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	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	Washington University School Of Medicine	Saint Louis	Missouri
United States	University of California San Francisco	San Francisco	California
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 2 year and 5 months
Primary	Number of Participants with AEs by Severity	Number of participants with AEs by severity will be reported.	Up to 2 year and 5 months
Primary	Number of Participants with Abnormalities in Laboratory Values	Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.	Up to 2 year and 5 months
Primary	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.	Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B)
Secondary	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.	Up to 2 year and 5 months
Secondary	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.	Up to 2 year and 5 months
Secondary	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.	Up to 2 year and 5 months
Secondary	Stringent Complete Response (sCR) Rate	sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria.	Up to 2 year and 5 months
Secondary	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.	Up to 2 year and 5 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 2 year and 5 months
Secondary	Serum Concentrations of Teclistamab	Serum concentrations of teclistamab will be reported.	Up to 2 year and 5 months
Secondary	Serum Concentrations of Daratumumab	Serum concentrations of daratumumab will be reported.	Up to 2 year and 5 months
Secondary	Serum Concentrations of Nirogacestat	Serum concentration of nirogacestat will be reported.	Up to 2 year and 5 months
Secondary	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.	Up to 2 year and 5 months
Secondary	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.	Up to 2 year and 5 months
Secondary	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.	Up to 2 year and 5 months