Description:
This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple
myeloma (MM) and what side effects (unwanted effects) may occur.
The study will have three parts. In the first part, participants get SEA-BCMA by itself. This
part of the study will find out how much SEA-BCMA should be given for treatment and how
often. It will also find out how safe the treatment is and how well it works.
In the second part of the study, participants will get SEA-BCMA and dexamethasone. In the
third part, participants will get SEA-BCMA, dexamethasone, and pomalidomide. Dexamethasone
and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of
the study will find out whether these drugs are safe when used together.
Title
- Brief Title: A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
- Official Title: A Phase 1 Study of SEA-BCMA in Patients With Relapsed or Refractory Multiple Myeloma
Clinical Trial IDs
- ORG STUDY ID:
SGNBCMA-001
- NCT ID:
NCT03582033
Conditions
Interventions
Drug | Synonyms | Arms |
---|
SEA-BCMA | | SEA-BCMA + Dexamethasone Combination Therapy |
dexamethasone | | SEA-BCMA + Dexamethasone Combination Therapy |
pomalidomide | | SEA-BCMA + Pomalidomide/Dexamethasone Combination Therapy |
Purpose
This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple
myeloma (MM) and what side effects (unwanted effects) may occur.
The study will have three parts. In the first part, participants get SEA-BCMA by itself. This
part of the study will find out how much SEA-BCMA should be given for treatment and how
often. It will also find out how safe the treatment is and how well it works.
In the second part of the study, participants will get SEA-BCMA and dexamethasone. In the
third part, participants will get SEA-BCMA, dexamethasone, and pomalidomide. Dexamethasone
and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of
the study will find out whether these drugs are safe when used together.
Trial Arms
Name | Type | Description | Interventions |
---|
SEA-BCMA Monotherapy | Experimental | SEA-BCMA | |
SEA-BCMA + Dexamethasone Combination Therapy | Experimental | SEA-BCMA + dexamethasone | |
SEA-BCMA + Pomalidomide/Dexamethasone Combination Therapy | Experimental | SEA-BCMA + dexamethasone + pomalidomide | - SEA-BCMA
- dexamethasone
- pomalidomide
|
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of MM
- Must have MM that is relapsed or refractory
- Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38
antibody
- Measurable disease, as defined by at least one of the following: (1) serum M protein
0.5 g/dL or higher, (2) urine M protein 200 mg/24 hour or higher, and (3) serum
immunoglobulin free light chain (FLC) 10 mg/dL or higher and abnormal serum
immunoglobulin kappa lambda FLC ratio.
- Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1
- Life expectancy of greater than 3 months in the opinion of the investigator
- Adequate hematologic, renal, and hepatic function
Exclusion Criteria:
- Prior treatment with a BCMA-directed therapy
- History of another malignancy within 3 years
- Active cerebral or meningeal disease related to the underlying malignancy
- Uncontrolled Grade 3 or higher infection
- Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of
study drug, or at least 2 weeks if progressing. Prior CAR-T-cell therapy must be
completed 8 weeks before first dose of study drug.
- Combination therapy only:
1. Known intolerance to corticosteroids
2. Uncontrolled psychoses
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of adverse events (AEs) |
Time Frame: | Through 30-37 days following last dose, up to approximately 3 years |
Safety Issue: | |
Description: | AE grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.03. Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant but not immediately life-threatening; Grade 4 - life-threatening consequences; Grade 5 - death related to AE |
Secondary Outcome Measures
Measure: | Pharmacokinetic (PK) outcome: Cmax (maximum serum concentration) |
Time Frame: | Through 30-37 days following last dose, up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | PK outcome: AUC (area under the serum concentration-time curve) |
Time Frame: | Through 84 days following first dose |
Safety Issue: | |
Description: | |
Measure: | Incidence of SEA-BCMA antitherapeutic antibodies (ATA) |
Time Frame: | Through 30-37 days following last dose, up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Best response per the IMWG uniform response criteria |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | International Myeloma Working Group (IMWG) |
Measure: | Objective response rate (ORR) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator |
Measure: | Duration of objective response (OR) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | The time from first documentation of OR to the first documentation of disease progression or death due to any cause |
Measure: | Duration of complete response (CR) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | The time from first documentation of CR to the first documentation of disease progression or death due to any cause |
Measure: | Progression-free survival (PFS) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | The time from the start of study treatment to the first documentation of disease progression or death due to any cause |
Measure: | Overall survival (OS) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | The time from the start of study treatment to the date of death due to any cause |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Seagen Inc. |
Trial Keywords
- RRMM
- Antibodies, monoclonal
- Antigens, BCMA
- Immunotherapy
- Hematologic diseases
- Myeloma
- Seattle Genetics
Last Updated
July 13, 2021