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

Multiple Myeloma Clinical Trial

— MajesTEC-4  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243797
• Other study ID #: EMN30/64007957MMY3003
• Status: Recruiting
• Phase: Phase 3
• Start date: September 8, 2022
• Est. completion date: April 2032

Study information

• Verified date: July 2023
• Source: European Myeloma Network
• Contact: Sarah Lonergan
• Phone: +31 107033123
• Email: sarah.lonergan[@]emn.life
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1572
• Est. completion date: April 2032
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
• Lenalidomide
Lenalidomide will be administered orally

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide
Australia	Barwon Health	Geelong
Australia	Alfred Hospital	Melbourne
Australia	Calvary Mater Hospital	Newcastle
Australia	Concord Hospital	Sydney
Australia	St Vincent's hospital	Sydney
Australia	Townsville Hospital	Townsville
Austria	Clinic Ottakring	Vienna
Belgium	University Hospital Leuven	Leuven
Brazil	AC Camargo Cancer Center	São Paulo
Czechia	University Hospital, Brno	Brno
Czechia	University Hospital Hradec Králové	Hradec Králové
Czechia	University Hospital, Olomouc	Olomouc
Czechia	University Hospital Ostrava	Ostrava
Czechia	University Hospital Pilsen	Pilsen
Czechia	General University Hospital, Prague	Praha
Denmark	Rigshospitalet	Copenhagen
Germany	University Hospital of Würzburg	Würzburg
Greece	Regional General Hospital Alexandra	Athens
Greece	St Savvas Cancer Hospital	Athens
Italy	A.O.U. di Bologna - Policlinico S. Orsola Malpighi	Bologna
Italy	A.O.Spedali Civili di Brescia	Brescia
Netherlands	Amsterdam Medical Center	Amsterdam
Netherlands	Erasmus MC, Rotterdam	Rotterdam
Norway	Oslo University Hospital	Oslo
Serbia	University Clinical Center of Serbia	Belgrade
Switzerland	Kantonsspital St. Gallen	Saint Gallen
Turkey	Ankara University	Ankara
United Kingdom	St James's University Hospital	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
European Myeloma Network	Janssen Pharmaceutica

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Brazil,  Czechia,  Denmark,  Germany,  Greece,  Italy,  Netherlands,  Norway,  Serbia,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	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.	from randomization to the date of disease progression or death (approximately up to 8 years)
Secondary	Comparison of efficacy	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	from randomization to the date of disease progression or death (approximately up to 8 years)
Secondary	Overall Survival (OS)	Overall Survival (OS), measured from the date of from randomization to the date the subject's death	from the date of from randomization to the date the subject's death, assessed up to 8 years]
Secondary	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	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.	baseline up to 8 years
Secondary	EQ-5D-5L health utility values and the difference between-treatment arms	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"	baseline up to 8 years
Secondary	MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms	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.	baseline up to 8 years
Secondary	PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms	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	baseline up to week 24
Secondary	PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms	PGIS is a 1 item questionnaire that evaluates patients' health and assesses if there has been an improvement or decline in clinical status	baseline up to 8 years