Back to resultsA Safety Study of SEA-BCMA in Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SEA-BCMA
dexamethasone
pomalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring RRMM, Antibodies, monoclonal, Antigens, BCMA, Immunotherapy, Hematologic diseases, Myeloma, Seattle Genetics
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:
- Parts A and D: 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:
- Known intolerance to corticosteroids
- Uncontrolled psychoses
Sites / Locations
- Stanford University School of Medicine
- Rocky Mountain Cancer Centers - Aurora
- University of Miami
- Holden Comprehensive Cancer Center / University of Iowa
- University of Kansas Cancer Center
- Washington University in St Louis
- Weill Cornell Medicine
- James P. Wilmot Cancer Center / University of Rochester Medical Center
- Willamette Valley Cancer Institute and Research Center
- Texas Oncology - Austin Midtown
- Texas Oncology - Northeast Texas
- Virginia Cancer Specialists, PC
- Fred Hutchinson Cancer Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Parts A and B: SEA-BCMA Monotherapy
Part C: SEA-BCMA + Dexamethasone Combination Therapy
Part D: SEA-BCMA + Pomalidomide + Dexamethasone Combination Therapy
Arm Description
SEA-BCMA
SEA-BCMA + dexamethasone
SEA-BCMA + dexamethasone + pomalidomide
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Number of participants with laboratory abnormalities by grade
Grades for laboratory abnormalities will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.03
Incidence of dose-limiting toxicities (DLTs)
To be summarized using descriptive statistics.
Secondary Outcome Measures
Pharmacokinetic (PK) outcome: Cmax (maximum serum concentration)
To be summarized using descriptive statistics.
PK outcome: AUC (area under the serum concentration-time curve)
To be summarized using descriptive statistics.
Incidence of SEA-BCMA antitherapeutic antibodies (ATA)
Best response per the IMWG uniform response criteria
International Myeloma Working Group (IMWG)
Objective response rate (ORR)
The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator
Duration of objective response (OR)
The time from first documentation of OR to the first documentation of disease progression or death due to any cause
Duration of complete response (CR)
The time from first documentation of CR to the first documentation of disease progression or death due to any cause
Progression-free survival (PFS)
The time from the start of study treatment to the first documentation of disease progression or death due to any cause
Overall survival (OS)
The time from the start of study treatment to the date of death due to any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03582033
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 several parts. In Parts A and B, 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 Part C of the study, participants will get SEA-BCMA and dexamethasone. In Part D, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
RRMM, Antibodies, monoclonal, Antigens, BCMA, Immunotherapy, Hematologic diseases, Myeloma, Seattle Genetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parts A and B: SEA-BCMA Monotherapy
Arm Type
Experimental
Arm Description
SEA-BCMA
Arm Title
Part C: SEA-BCMA + Dexamethasone Combination Therapy
Arm Type
Experimental
Arm Description
SEA-BCMA + dexamethasone
Arm Title
Part D: SEA-BCMA + Pomalidomide + Dexamethasone Combination Therapy
Arm Type
Experimental
Arm Description
SEA-BCMA + dexamethasone + pomalidomide
Intervention Type
Drug
Intervention Name(s)
SEA-BCMA
Intervention Description
Given into the vein (IV; intravenously)
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
Given by mouth (orally) or by IV
Intervention Type
Drug
Intervention Name(s)
pomalidomide
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Description
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time Frame
Through 30-37 days following last dose, up to approximately 3 years
Title
Number of participants with laboratory abnormalities by grade
Description
Grades for laboratory abnormalities will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.03
Time Frame
Through 30-37 days following last dose, up to approximately 3 years
Title
Incidence of dose-limiting toxicities (DLTs)
Description
To be summarized using descriptive statistics.
Time Frame
Through up to 28 days following first dose
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) outcome: Cmax (maximum serum concentration)
Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days following last dose, up to approximately 3 years
Title
PK outcome: AUC (area under the serum concentration-time curve)
Description
To be summarized using descriptive statistics.
Time Frame
Through 84 days following first dose
Title
Incidence of SEA-BCMA antitherapeutic antibodies (ATA)
Time Frame
Through 30-37 days following last dose, up to approximately 4 years
Title
Best response per the IMWG uniform response criteria
Description
International Myeloma Working Group (IMWG)
Time Frame
Up to approximately 5 years
Title
Objective response rate (ORR)
Description
The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator
Time Frame
Up to approximately 4 years
Title
Duration of objective response (OR)
Description
The time from first documentation of OR to the first documentation of disease progression or death due to any cause
Time Frame
Up to approximately 4 years
Title
Duration of complete response (CR)
Description
The time from first documentation of CR to the first documentation of disease progression or death due to any cause
Time Frame
Up to approximately 4 years
Title
Progression-free survival (PFS)
Description
The time from the start of study treatment to the first documentation of disease progression or death due to any cause
Time Frame
Up to approximately 4 years
Title
Overall survival (OS)
Description
The time from the start of study treatment to the date of death due to any cause
Time Frame
Up to approximately 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
Parts A and D: 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:
Known intolerance to corticosteroids
Uncontrolled psychoses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Hayman, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Holden Comprehensive Cancer Center / University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Washington University in St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
James P. Wilmot Cancer Center / University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Texas Oncology - Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology - Northeast Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
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