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.
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
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
+31 10 268 70 65
Central Contact Email
Christine.Witty@emn.org
Central Contact Role
Contact
Central Contact Phone
+31 10 268 70 65
Central Contact Email
Sabrin.Tahri@emn.org
Completion Date
Completion Date Type
Estimated
Conditions
Multiple Myeloma
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Maintenance
Teclistamab
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05243797
Org Class
Network
Org Full Name
European Myeloma Network B.V.
Org Study Id
EMN30/64007957MMY3003
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome 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.
Outcome Measure
Progression Free Survival (PFS)
Outcome Time Frame
from randomization to the date of disease progression or death (approximately up to 8 years)
Outcome Description
12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation flow cytometry (NGF) with sensitivity of 10\^-5, prior to progressive disease or subsequent anti-myeloma therapy, whichever is earlier, and who also achieve CR of better, according to IMWG criteria.
Outcome Measure
Minimal Residual Disease (MRD)-negative Complete Response (CR)
Outcome Time Frame
at month 12
Secondary Outcomes
Outcome 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
Outcome Time Frame
from randomization to the date of disease progression or death (approximately up to 8 years)
Outcome Measure
Comparison of efficacy
Outcome Description
Overall Survival (OS), measured from the date of from randomization to the date the subject's death
Outcome Time Frame
from the date of from randomization to the date the subject's death, assessed up to 8 years]
Outcome Measure
Overall Survival (OS)
Outcome 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.
Outcome Time Frame
baseline up to 8 years
Outcome Measure
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
Outcome 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"
Outcome Time Frame
baseline up to 8 years
Outcome Measure
EQ-5D-5L health utility values and the difference between-treatment arms
Outcome 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.
Outcome Time Frame
baseline up to 8 years
Outcome Measure
MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms
Outcome 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
Outcome Time Frame
baseline up to week 24
Outcome Measure
PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms
Outcome Description
PGIS is a 1 item questionnaire that evaluates patients' health and assesses if there has been an improvement or decline in clinical status
Outcome Time Frame
baseline up to 8 years
Outcome Measure
PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Levitz
Investigator Email
dlevitz@montefiore.org
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Blood & Bone Marrow Cancers --- MULTIPLE MYELOMA
Blood & Bone Marrow Cancers --- NEOPLASMS, PLASMA CELL
Cancer --- NEOPLASMS
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Blood Disorders --- HEMATOLOGIC DISEASES
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
MULTIPLE MYELOMA
NEOPLASMS, PLASMA CELL
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
HEMOSTATIC DISORDERS
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
PARAPROTEINEMIAS
BLOOD PROTEIN DISORDERS
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
HEMORRHAGIC DISORDERS
LYMPHOPROLIFERATIVE DISORDERS
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
LENALIDOMIDE
PHTHALIMIDES
PHTHALIC ACIDS
ACIDS, CARBOCYCLIC
CARBOXYLIC ACIDS
ORGANIC CHEMICALS
PIPERIDONES
PIPERIDINES
HETEROCYCLIC COMPOUNDS, 1-RING
HETEROCYCLIC COMPOUNDS
ISOINDOLES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING