Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.
Interventions
DRUGCevostamab
Participants will receive cevostamab IV as per the schedule given in the protocol.
DRUGPomalidomide
Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol.
DRUGDexamethasone
Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol.
DRUGDaratumumab
Participants will receive daratumumab SC as per the schedule given in the protocol.
DRUGElotuzumab
Participants will receive elotuzumab IV as per the schedule given in the protocol.
DRUGCarfilzomib
Participants will receive carfilzomib IV as per the schedule given in the protocol.
Sponsors
Hoffmann-La Roche
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
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to start of administration of study treatment. * Individuals with ECOG Performance Status of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible * MM diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria * Received one to three lines of prior therapy that included at least two consecutive cycles of either of the following: A regimen containing an anti-CD38 therapy, a regimen containing lenalidomide * Participants must have measurable disease during screening
Exclusion criteria
* Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan) * Plasma cell leukemia or circulating plasma cell count exceeding 500 cells/liter (L) or 5% of the peripheral blood white cells * GI disease that might significantly alter absorption of oral drugs * Participants must not have any ongoing CNS disease or non-secretory myeloma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal Residual Disease (MRD)-Negative Complete Response (CR) Rate | Up to 1 year after the last participant is randomized |
| Progression-Free Survival (PFS) | Up to 5 years after the last participant is randomized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Very Good Partial Response (VGPR) or Better Rate | Up to 5 years after the last participant is randomized | — |
| Overall Survival (OS) | Up to 5 years after the last participant is randomized | — |
| Time to Confirmed Deterioration in the Disease Symptoms Scale as Assessed by the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Multiple Myeloma Module 20 (MY20) | Up to 5 years after the last participant is randomized | Primary domains: fatigue, pain, physical functioning, cognitive functioning and global health status. |
| Overall Response Rate (ORR) | Up to 5 years after the last participant is randomized | — |
| Complete Response (CR) Rate | Up to 5 years after the last participant is randomized | — |
| Time to Response (TTR) | Up to 5 years after the last participant is randomized | — |
| Time to Best Response (TTBR) | Up to 5 years after the last participant is randomized | — |
| Duration of Response (DOR) | Up to 5 years after the last participant is randomized | — |
| Progression-Free Survival (PFS) | Up to 5 years after the last participant is randomized | — |
| Progression-Free Survival 2 (PFS2) | Up to 5 years after the last participant is randomized | — |
| Overall MRD-Negative Complete Response Rate | Up to 5 years after the last participant is randomized | — |
| Overall MRD-Negative Rate | Up to 5 years after the last participant is randomized | — |
| Sustained MRD-Negative CR Rate | At 6, 12, and 24 months | — |
| Percentage of Participants With Adverse Events (AEs) | Up to 5 years after the last participant is randomized | — |
| Tolerability as Assessed by the Incidence of Dose Interruptions, Dose Reductions, Dose Intensity, and Treatment Discontinuation | Up to 5 years after the last participant is randomized | — |
| Number of Participants With Presence, Frequency of Occurrence, Severity, and/or Degree of Interference With Daily Function of Shortness of Breath, Cough, Heart Palpitations, Rash, Dizziness, and Nausea Assessed NCI PRO-CTCAE | Up to 5 years after the last participant is randomized | — |
| Change From Baseline in Shortness of Breath, Cough, Heart Palpitations, Rash, Dizziness, and Nausea Assessed by the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) | Baseline and up to 5 years after the last participant is randomized | — |
| Change From Cycle 1 Day 8 in Treatment-Related Side Effect Bother as Assessed by the Functional Assessment of Cancer Therapy-General, General Population 5 (FACTG GP5) | At Day 8 of Cycle 1, up to 5 years after the last participant is randomized. Cycle 1 is 21 days. | — |
| Change From Baseline in the Disease Symptom Scale of the EORTC QLQ-MY20 | Baseline and Up to 5 years after the last participant is randomized | — |
| Change from Baseline in the Global Health Status/Quality of Life (GHS/QoL) of the EORTC QLQ-Core 30 (C30) | Baseline and Up to 5 years after the last participant is randomized | — |
| Time to Confirmed Deterioration in GHS/QoL as Assessed by the EORTC QLQ-C30 | Up to 5 years after the last participant is randomized | — |
| Change From Baseline in Fatigue as Assessed by the EORTC QLQ-C30 | Baseline and up to 5 years after the last participant is randomized | — |
| Time to Confirmed Deterioration in Fatigue as Assessed by the EORTC QLQ-C30 | Up to 5 years after the last participant is randomized | — |
| Percentage of Participants Experiencing Clinically Meaningful Improvement in Disease Symptoms as Assessed by the EORTC QLQ-MY20 | Up to 5 years after the last participant is randomized | — |
| Percentage of Participants Experiencing Clinically Meaningful Improvement in GHS/QoL as Assessed by the EORTC QLQ-C30 | Up to 5 years after the last participant is randomized | — |
| Percentage of Participants Experiencing Clinically Meaningful Improvement in Fatigue as Assessed by the EORTC QLQ-C30 | Up to 5 years after the last participant is randomized | — |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline and with ADAs to Cevostamab During the Study | Baseline and up to 5 years after the last participant is randomized | — |
Contacts
CONTACTReference Study ID Number: CO46096 https://forpatients.roche.com/
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed