A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Relapsed or Refractory Multiple Myeloma Clinical Trial

— MajesTEC-10  

Official title:

A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425991
• Other study ID #: 64007957MMY1008
• Secondary ID: 64007957MMY10082
• Status: Recruiting
• Phase: Phase 1
• Start date: June 7, 2024
• Est. completion date: January 2, 2027

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2, 2027
• Est. primary completion date: July 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented diagnosis of multiple myeloma as defined by the criteria below: (a) Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
• Received 1 to 3 prior lines of antimyeloma therapy, including a minimum of 2 consecutive cycles each of a protease inhibitor (PI), lenalidomide, and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (or minimum of 6 doses if anti CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line
• Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria
• Have an eastern cooperative oncology group (ECOG) performance status score of 0 to 2
• A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study

Exclusion Criteria:

• Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy
• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
• Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed
• Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology may be required
• Participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

Drug:
• Teclistamab
Teclistamab will be administered subcutaneously.

Locations

Country	Name	City	State
Australia	Epworth Healthcare	Richmond
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St Mary s Hospital	Seoul
United States	Cleveland Clinic	Cleveland	Ohio
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab	Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose).	Cycle 1 (28 days cycle): Predose to Day 7 postdose
Primary	Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose	AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose).	Cycle 1 (28 days cycle): Predose to Day 7 postdose
Primary	Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1	Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration.	Cycle 3 (28 days cycle): Day 1
Secondary	Number of Participants with Anti-drug Antibodies (ADAs)	Number of participants with ADAs to teclistamab will be reported.	Up to approximately 3 years
Secondary	Percentage of Participants With Complete Response (CR) or Better Response	Percentage of participants with CR or better response will be reported. CR or better response rate is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.	Up to approximately 3 years
Secondary	Number of Participants with Adverse Events (AEs) by Severity	An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. 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, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.	Up to approximately 3 years
Secondary	Number of Participants with Serious Adverse Events (SAEs)	SAEs are any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.	Up to approximately 3 years
Secondary	Number of Participants with Abnormal Laboratory Results	Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported.	Up to approximately 3 years
Secondary	Percentage of Participants With Overall Response (Partial Response [PR] or Better)	Percentage of participants with overall response (PR or better) will be reported. Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria.	Up to approximately 3 years
Secondary	Percentage of Participants With Very Good Partial Response (VGPR) or Better Response	Percentage of participants with VGPR or better response will be reported. VGPR or better response rate is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.	Up to approximately 3 years