MajesTEC-4: A Study of Teclistamab in Combination With Lenalidomide Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
Study Details
Study Description
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 versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Arm A: Teclistamab-Lenalidomide (Tec-Len)
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Drug: Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
Other Names:
Drug: Lenalidomide
Lenalidomide will be administered orally
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Active Comparator: Arm B Lenalidomide Alone (Len) Lenalidomide orally. |
Drug: Lenalidomide
Lenalidomide will be administered orally
|
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 rate, sustained MRD negativity rate as per the IMWG criteria
- 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
- Safety of Tec-Len versus Len alone [continuously from screening until 30 days after last study treatment. (approximately 2 years or until progressive disease)]
Safety and tolerability of study treatment will be evaluated based on occurrence, nature and severity of adverse events as categorized by the Common Terminology Criteria of Adverse Events (CTCAE) v5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
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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.
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Must not be intolerant to the starting dose of lenalidomide.
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Must not have received any maintenance therapy.
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Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
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Have clinical laboratory values within prespecified range.
Exclusion Criteria:
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Received any prior BCMA-directed therapy.
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Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).
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Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
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Progressed on multiple myeloma therapy at any time prior to screening.
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Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose (see Appendix 12).
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Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines authorized for emergency use (eg. COVID-19) are allowed.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Alfred Hospital | Melbourne | Australia | ||
2 | Clinic Ottakring | Vienna | Austria | ||
3 | University Hospital Leuven | Leuven | Belgium | ||
4 | University Hospital Ostrava | Ostrava | Czechia | ||
5 | Rigshospitalet | Copenhagen | Denmark | ||
6 | University Hospital of Würzburg | Würzburg | Germany | ||
7 | Regional General Hospital Alexandra | Athens | Greece | ||
8 | A.O.U. di Bologna - Policlinico S. Orsola Malpighi | Bologna | Italy | ||
9 | Amsterdam Medical Center | Amsterdam | Netherlands | ||
10 | Oslo University Hospital | Oslo | Norway | ||
11 | University Clinical Center of Serbia | Belgrade | Serbia | ||
12 | Kantonsspital St. Gallen | Saint Gallen | Switzerland | ||
13 | Ankara University | Ankara | Turkey | ||
14 | St James's University Hospital | Leeds | United Kingdom |
Sponsors and Collaborators
- European Myeloma Network
- Janssen Pharmaceutica
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EMN30/64007957MMY3003