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

Sponsor

Seagen Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03582033

Collaborator

(none)

131

Enrollment

Locations

Arms

87.9

Anticipated Duration (Months)

11.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: SEA-BCMA Drug: dexamethasone Drug: pomalidomide	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

131 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Feb 28, 2025

Anticipated Study Completion Date :

Feb 28, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Parts A and B: SEA-BCMA Monotherapy SEA-BCMA	Drug: SEA-BCMA Given into the vein (IV; intravenously)
Experimental: Part C: SEA-BCMA + Dexamethasone Combination Therapy SEA-BCMA + dexamethasone	Drug: SEA-BCMA Given into the vein (IV; intravenously) Drug: dexamethasone Given by mouth (orally) or by IV
Experimental: Part D: SEA-BCMA + Pomalidomide + Dexamethasone Combination Therapy SEA-BCMA + dexamethasone + pomalidomide	Drug: SEA-BCMA Given into the vein (IV; intravenously) Drug: dexamethasone Given by mouth (orally) or by IV Drug: pomalidomide Given orally

Arm

Intervention/Treatment

Experimental: Parts A and B: SEA-BCMA Monotherapy

SEA-BCMA

Drug: SEA-BCMA

Given into the vein (IV; intravenously)

Experimental: Part C: SEA-BCMA + Dexamethasone Combination Therapy

SEA-BCMA + dexamethasone

Drug: SEA-BCMA

Given into the vein (IV; intravenously)

Drug: dexamethasone

Given by mouth (orally) or by IV

Experimental: Part D: SEA-BCMA + Pomalidomide + Dexamethasone Combination Therapy

SEA-BCMA + dexamethasone + pomalidomide

Drug: SEA-BCMA

Given into the vein (IV; intravenously)

Drug: dexamethasone

Given by mouth (orally) or by IV

Drug: pomalidomide

Given orally

Outcome Measures

Primary Outcome Measures

Incidence of adverse events (AEs) [Through 30-37 days following last dose, up to approximately 3 years]
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 [Through 30-37 days following last dose, up to approximately 3 years]
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) [Through up to 28 days following first dose]
To be summarized using descriptive statistics.

Secondary Outcome Measures

Pharmacokinetic (PK) outcome: Cmax (maximum serum concentration) [Through 30-37 days following last dose, up to approximately 3 years]
To be summarized using descriptive statistics.
PK outcome: AUC (area under the serum concentration-time curve) [Through 84 days following first dose]
To be summarized using descriptive statistics.
Incidence of SEA-BCMA antitherapeutic antibodies (ATA) [Through 30-37 days following last dose, up to approximately 4 years]
Best response per the IMWG uniform response criteria [Up to approximately 5 years]
International Myeloma Working Group (IMWG)
Objective response rate (ORR) [Up to approximately 4 years]
The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator
Duration of objective response (OR) [Up to approximately 4 years]
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) [Up to approximately 4 years]
The time from first documentation of CR to the first documentation of disease progression or death due to any cause
Progression-free survival (PFS) [Up to approximately 4 years]
The time from the start of study treatment to the first documentation of disease progression or death due to any cause
Overall survival (OS) [Up to approximately 4 years]
The time from the start of study treatment to the date of death due to any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Palo Alto	California	United States	94304
2	Rocky Mountain Cancer Centers - Aurora	Aurora	Colorado	United States	80012
3	University of Miami	Miami	Florida	United States	33136
4	Holden Comprehensive Cancer Center / University of Iowa	Iowa City	Iowa	United States	52242
5	University of Kansas Cancer Center	Westwood	Kansas	United States	66205
6	Washington University in St Louis	Saint Louis	Missouri	United States	63110
7	Weill Cornell Medicine	New York	New York	United States	10065
8	James P. Wilmot Cancer Center / University of Rochester Medical Center	Rochester	New York	United States	14642
9	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon	United States	97401
10	Texas Oncology - Austin Midtown	Austin	Texas	United States	78705
11	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109-1024