A Safety Study of SEA-BCMA in Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase 1 Study of SEA-BCMA in Patients With Relapsed or Refractory Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03582033
• Other study ID #: SGNBCMA-001
• Status: Terminated
• Phase: Phase 1
• Start date: November 1, 2018
• Est. completion date: November 9, 2023

Study information

• Verified date: November 2023
• Source: Seagen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Known intolerance to corticosteroids

2. Uncontrolled psychoses

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• SEA-BCMA
Given into the vein (IV; intravenously)
• dexamethasone
Given by mouth (orally) or by IV
• pomalidomide
Given orally

Locations

Country	Name	City	State
United States	Rocky Mountain Cancer Centers - Aurora	Aurora	Colorado
United States	Texas Oncology - Austin Midtown	Austin	Texas
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	Holden Comprehensive Cancer Center / University of Iowa	Iowa City	Iowa
United States	University of Miami	Miami	Florida
United States	Weill Cornell Medicine	New York	New York
United States	Stanford University School of Medicine	Palo Alto	California
United States	James P. Wilmot Cancer Center / University of Rochester Medical Center	Rochester	New York
United States	Washington University in St Louis	Saint Louis	Missouri
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Texas Oncology - Northeast Texas	Tyler	Texas
United States	University of Kansas Cancer Center	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through 30-37 days following last dose, up to approximately 3 years
Primary	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	Through 30-37 days following last dose, up to approximately 3 years
Primary	Incidence of dose-limiting toxicities (DLTs)	To be summarized using descriptive statistics.	Through up to 28 days following first dose
Secondary	Pharmacokinetic (PK) outcome: Cmax (maximum serum concentration)	To be summarized using descriptive statistics.	Through 30-37 days following last dose, up to approximately 3 years
Secondary	PK outcome: AUC (area under the serum concentration-time curve)	To be summarized using descriptive statistics.	Through 84 days following first dose
Secondary	Incidence of SEA-BCMA antitherapeutic antibodies (ATA)		Through 30-37 days following last dose, up to approximately 4 years
Secondary	Best response per the IMWG uniform response criteria	International Myeloma Working Group (IMWG)	Up to approximately 5 years
Secondary	Objective response rate (ORR)	The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator	Up to approximately 4 years
Secondary	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	Up to approximately 4 years
Secondary	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	Up to approximately 4 years
Secondary	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	Up to approximately 4 years
Secondary	Overall survival (OS)	The time from the start of study treatment to the date of death due to any cause	Up to approximately 4 years