Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation - MajesTEC-4
ClinicalTrials.gov processed this data on November 19, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified November 2024 by Stichting European Myeloma Network, Janssen Pharmaceutica
Sponsor
Stichting European Myeloma NetworkInformation Provided by (Responsible Party)
Stichting European Myeloma NetworkClinicaltrials.gov Identifier
NCT05243797Other Study ID Numbers: EMN30/64007957MMY3003
First Submitted: January 27, 2022
First Posted: February 17, 2022
Last Update Posted: November 20, 2024
Last Verified: November 2024
History of Changes
Disclaimer
Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.
Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.
Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.
For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.
See also the Web Policies and Notices for the NIH web site.
Study Description
Not Provided| Condition or Disease | Intervention/Treatment |
|---|---|
|
|
Study Design
| Study Type | Interventional |
|---|---|
| Anticipated Enrollment | 1572 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | None (Open Label) |
| Primary Purpose | Treatment |
| Official Title | Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation - MajesTEC-4 |
| Study Start Date | September 8, 2022 |
| Anticipated Primary Completion Date | April 2028 |
| Anticipated Study Completion Date | April 2032 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
|---|---|
|
|
|
|
|
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival (PFS) [from randomization to the date of disease progression or death (approximately up to 8 years)] PFS is defined as the time from the date of randomization to the date of disease progression (as assessed by IMWG criteria) or death due to any cause, whichever occurs first.
Secondary Outcome Measures
- Comparison of efficacy [from randomization to the date of disease progression or death (approximately up to 8 years)] Efficacy, assessed by rate of CR or better, MRD negative CR, sustained MRD negativity, CR and MRD negative conversion PFS after next line of therapy (PFS2), time to next treatment (TTNT), OS and also safety, PK and immunogenicity
- Overall Survival (OS) [from the date of from randomization to the date the subject's death, assessed up to 8 years]] Overall Survival (OS), measured from the date of from randomization to the date the subject's death
- Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) score and the difference between-treatment arms [baseline up to 8 years] The EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-of-Life (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology.
- EQ-5D-5L health utility values and the difference between-treatment arms [baseline up to 8 years] The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today"
- MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms [baseline up to 8 years] The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days", and responses are reported on a 5-point verbal rating scale.
- PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms [baseline up to week 24] The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The PRO-CTCAE Item Library includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE
- PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms [baseline up to 8 years] PGIS is a 1 item questionnaire that evaluates patients' health and assesses if there has been an improvement or decline in clinical status
Eligibility Criteria
| Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
|
| Exclusion Criteria |
|
Contacts and Locations
| Sponsors and Collaborators | Stichting European Myeloma Network, Janssen Pharmaceutica |
|---|---|
| Janssen Pharmaceutica | |
| Locations |
|
| Investigators |
|
More Information
Additional Relevant MeSH Terms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Neoplasms by Histologic Type
- Neoplasms
- Hemostatic Disorders
- Vascular Diseases
- Cardiovascular Diseases
- Paraproteinemias
- Blood Protein Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Immune System Diseases