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)
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| ClinicalTrials.gov Identifier: NCT05243797 |
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Recruitment Status :
Recruiting
First Posted : February 17, 2022
Last Update Posted : July 6, 2023
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Sponsor:
Stichting European Myeloma Network
Collaborator:
Janssen Pharmaceutica
Information provided by (Responsible Party):
Stichting European Myeloma Network
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Brief Summary:
This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Teclistamab Drug: Lenalidomide | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1572 participants |
| Allocation: | Randomized |
| Intervention 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 |
| Actual Study Start Date : | September 8, 2022 |
| Estimated Primary Completion Date : | April 2028 |
| Estimated Study Completion Date : | April 2032 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
Drug Information
available for:
Lenalidomide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A: Teclistamab-Lenalidomide (Tec-Len)
Teclistamab will be administered via a subcutaneous injection (SC)
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Drug: Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
Other Name: JNJ-64007957 Drug: Lenalidomide Lenalidomide will be administered orally |
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Active Comparator: Arm B Lenalidomide Alone (Len)
Lenalidomide orally.
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Drug: Lenalidomide
Lenalidomide will be administered orally |
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Experimental: Arm C Teclistamab-Alone (Tec)
Teclistamab will be administered via a subcutaneous injection (SC)
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Drug: Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
Other Name: JNJ-64007957 |
Primary Outcome Measures :
- Progression Free Survival (PFS) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
- Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression at the time of first treatment dose.
- Must not be intolerant to the starting dose of lenalidomide.
- Must not have received any maintenance therapy.
- Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
- Have clinical laboratory values within prespecified range.
Exclusion Criteria:
- Received any prior BCMA-directed therapy.
- Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).
- Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
- Progressed on multiple myeloma therapy at any time prior to screening.
- Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose.
- Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are allowed.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05243797
Contacts
| Contact: Sarah Lonergan | +31 107033123 | sarah.lonergan@emn.life |
Locations
Show 29 study locations
Sponsors and Collaborators
Stichting European Myeloma Network
Janssen Pharmaceutica
| Responsible Party: | Stichting European Myeloma Network |
| ClinicalTrials.gov Identifier: | NCT05243797 |
| Other Study ID Numbers: |
EMN30/64007957MMY3003 |
| First Posted: | February 17, 2022 Key Record Dates |
| Last Update Posted: | July 6, 2023 |
| Last Verified: | July 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by Stichting European Myeloma Network:
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Maintenance Teclistamab |
Additional relevant MeSH terms:
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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 Lenalidomide Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |