search
Back to results

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)

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Teclistamab
Lenalidomide
Sponsored by
European Myeloma Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Maintenance, Teclistamab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (see Appendix 12).
  • Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines authorized for emergency use (eg. COVID-19) are allowed.

Sites / Locations

  • Flinders Medical Centre
  • Barwon HealthRecruiting
  • Alfred HospitalRecruiting
  • Calvary Mater HospitalRecruiting
  • Concord HospitalRecruiting
  • St Vincent's hospitalRecruiting
  • Townsville HospitalRecruiting
  • Clinic Ottakring
  • University Hospital Leuven
  • AC Camargo Cancer Center
  • University Hospital, BrnoRecruiting
  • University Hospital Hradec KrálovéRecruiting
  • University Hospital, OlomoucRecruiting
  • University Hospital OstravaRecruiting
  • University Hospital PilsenRecruiting
  • General University Hospital, PragueRecruiting
  • Rigshospitalet
  • University Hospital of Würzburg
  • Regional General Hospital AlexandraRecruiting
  • St Savvas Cancer HospitalRecruiting
  • A.O.U. di Bologna - Policlinico S. Orsola MalpighiRecruiting
  • A.O.Spedali Civili di BresciaRecruiting
  • Amsterdam Medical Center
  • Erasmus MC, Rotterdam
  • Oslo University Hospital
  • University Clinical Center of Serbia
  • Kantonsspital St. GallenRecruiting
  • Ankara University
  • St James's University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Arm A: Teclistamab-Lenalidomide (Tec-Len)

Arm B Lenalidomide Alone (Len)

Arm C Teclistamab-Alone (Tec)

Arm Description

Teclistamab will be administered via a subcutaneous injection (SC)

Lenalidomide orally.

Teclistamab will be administered via a subcutaneous injection (SC)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Overall Survival (OS)
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
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
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
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
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
PGIS is a 1 item questionnaire that evaluates patients' health and assesses if there has been an improvement or decline in clinical status

Full Information

First Posted
January 27, 2022
Last Updated
July 4, 2023
Sponsor
European Myeloma Network
Collaborators
Janssen Pharmaceutica
search

1. Study Identification

Unique Protocol Identification Number
NCT05243797
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
April 2028 (Anticipated)
Study Completion Date
April 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Myeloma Network
Collaborators
Janssen Pharmaceutica

4. Oversight

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
Data Monitoring Committee
Yes

5. 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 and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Maintenance, Teclistamab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1572 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Teclistamab-Lenalidomide (Tec-Len)
Arm Type
Experimental
Arm Description
Teclistamab will be administered via a subcutaneous injection (SC)
Arm Title
Arm B Lenalidomide Alone (Len)
Arm Type
Active Comparator
Arm Description
Lenalidomide orally.
Arm Title
Arm C Teclistamab-Alone (Tec)
Arm Type
Experimental
Arm Description
Teclistamab will be administered via a subcutaneous injection (SC)
Intervention Type
Drug
Intervention Name(s)
Teclistamab
Other Intervention Name(s)
JNJ-64007957
Intervention Description
Teclistamab will be administered via a subcutaneous injection (SC)
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide will be administered orally
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
from randomization to the date of disease progression or death (approximately up to 8 years)
Secondary Outcome Measure Information:
Title
Comparison of efficacy
Description
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
Time Frame
from randomization to the date of disease progression or death (approximately up to 8 years)
Title
Overall Survival (OS)
Description
Overall Survival (OS), measured from the date of from randomization to the date the subject's death
Time Frame
from the date of from randomization to the date the subject's death, assessed up to 8 years]
Title
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
Description
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.
Time Frame
baseline up to 8 years
Title
EQ-5D-5L health utility values and the difference between-treatment arms
Description
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"
Time Frame
baseline up to 8 years
Title
MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms
Description
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.
Time Frame
baseline up to 8 years
Title
PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms
Description
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
Time Frame
baseline up to week 24
Title
PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms
Description
PGIS is a 1 item questionnaire that evaluates patients' health and assesses if there has been an improvement or decline in clinical status
Time Frame
baseline up to 8 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Lonergan
Phone
+31 107033123
Email
sarah.lonergan@emn.life
Facility Information:
Facility Name
Flinders Medical Centre
City
Adelaide
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coghlan
Facility Name
Barwon Health
City
Geelong
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sirdesai
Facility Name
Alfred Hospital
City
Melbourne
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Spencer
Facility Name
Calvary Mater Hospital
City
Newcastle
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janowski
Facility Name
Concord Hospital
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wong Doo
Facility Name
St Vincent's hospital
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
McCaughan
Facility Name
Townsville Hospital
City
Townsville
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Choong Lai
Facility Name
Clinic Ottakring
City
Vienna
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Schreder
Facility Name
University Hospital Leuven
City
Leuven
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delforge
Facility Name
AC Camargo Cancer Center
City
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lemos Moura
Facility Name
University Hospital, Brno
City
Brno
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pour
Facility Name
University Hospital Hradec Králové
City
Hradec Králové
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radocha
Facility Name
University Hospital, Olomouc
City
Olomouc
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minarik
Facility Name
University Hospital Ostrava
City
Ostrava
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hajek
Facility Name
University Hospital Pilsen
City
Pilsen
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lungova
Facility Name
General University Hospital, Prague
City
Praha
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Spicka
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Szabo
Facility Name
University Hospital of Würzburg
City
Würzburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Einsele
Facility Name
Regional General Hospital Alexandra
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terpos
Facility Name
St Savvas Cancer Hospital
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pouli
Facility Name
A.O.U. di Bologna - Policlinico S. Orsola Malpighi
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zamagni
Facility Name
A.O.Spedali Civili di Brescia
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belotti
Facility Name
Amsterdam Medical Center
City
Amsterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
van der Donk
Facility Name
Erasmus MC, Rotterdam
City
Rotterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wester
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Schjesvold
Facility Name
University Clinical Center of Serbia
City
Belgrade
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bila
Facility Name
Kantonsspital St. Gallen
City
Saint Gallen
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silzle
Facility Name
Ankara University
City
Ankara
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beksac
Facility Name
St James's University Hospital
City
Leeds
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cook

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs