Multiple Myeloma
Conditions
Keywords
Maintenance, Teclistamab
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.
Interventions
DRUGTeclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
DRUGLenalidomide
Lenalidomide will be administered orally
Sponsors
European Myeloma Network B.V.
Janssen Pharmaceutica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Minimal Residual Disease (MRD)-negative Complete Response (CR) | at month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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, 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) | 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 |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Serbia, South Korea, Switzerland, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTChristine Witty
CONTACTSabrin Tahri
PRINCIPAL_INVESTIGATORNiels van de Donk, Professor
Amsterdam UMC, Vrije Universiteit Amsterdam
PRINCIPAL_INVESTIGATORElena Zamagni, Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli"
Outcome results
None listed