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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03582033
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Seagen Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Phoenix Ho, MD
Principal Investigator Affiliation Seagen Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

Experimental: SEA-BCMA Monotherapy

SEA-BCMA

Experimental: SEA-BCMA + Dexamethasone Combination Therapy

SEA-BCMA + dexamethasone

Experimental: SEA-BCMA + Pomalidomide/Dexamethasone Combination Therapy

SEA-BCMA + dexamethasone + pomalidomide

Interventions

Drug: - SEA-BCMA

Given into the vein (IV; intravenously)

Drug: - dexamethasone

Given by mouth (orally) or by IV

Drug: - pomalidomide

Given orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University School of Medicine, Palo Alto, California

Status

Recruiting

Address

Stanford University School of Medicine

Palo Alto, California, 94304

Site Contact

Seagen Trial Information Support

clinicaltrials@seagen.com

866-333-7436

Rocky Mountain Cancer Centers - Aurora, Aurora, Colorado

Status

Recruiting

Address

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, 80012

Site Contact

Seagen Trial Information Support

clinicaltrials@seagen.com

866-333-7436

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Site Contact

Seagen Trial Information Support

clinicaltrials@seagen.com

866-333-7436

Iowa City, Iowa

Status

Recruiting

Address

Holden Comprehensive Cancer Center / University of Iowa

Iowa City, Iowa, 52242

Site Contact

Seagen Trial Information Support

clinicaltrials@seagen.com

866-333-7436

University of Kansas Cancer Center, Westwood, Kansas

Status

Recruiting

Address

University of Kansas Cancer Center

Westwood, Kansas, 66205

Site Contact

Seagen Trial Information Support

clinicaltrials@seagen.com

866-333-7436

Washington University in St Louis, Saint Louis, Missouri

Status

Recruiting

Address

Washington University in St Louis

Saint Louis, Missouri, 63110

Site Contact

Seagen Trial Information Support

clinicaltrials@seagen.com

866-333-7436

Weill Cornell Medicine, New York, New York

Status

Recruiting

Address

Weill Cornell Medicine

New York, New York, 10065

Site Contact

Seagen Trial Information Support

clinicaltrials@seagen.com

866-333-7436

Rochester, New York

Status

Recruiting

Address

James P. Wilmot Cancer Center / University of Rochester Medical Center

Rochester, New York, 14642

Site Contact

Seagen Trial Information Support

clinicaltrials@seagen.com

866-333-7436

Eugene, Oregon

Status

Recruiting

Address

Willamette Valley Cancer Institute/Oncology Assc of Oregon

Eugene, Oregon, 97401

Site Contact

Seagen Trial Information Support

clinicaltrials@seagen.com

866-333-7436

Texas Oncology - Austin Midtown, Austin, Texas

Status

Recruiting

Address

Texas Oncology - Austin Midtown

Austin, Texas, 78705

Site Contact

Seagen Trial Information Support

clinicaltrials@seagen.com

866-333-7436

Fred Hutchinson Cancer Research Center, Seattle, Washington

Status

Recruiting

Address

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024

Site Contact

Seagen Trial Information Support

clinicaltrials@seagen.com

866-333-7436