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

Sponsor
Seagen Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03582033
Collaborator
(none)
305
Enrollment
11
Locations
4
Arms
56.9
Anticipated Duration (Months)
27.7
Patients Per Site
0.5
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 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 either pomalidomide or nirogacestat. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. Nirogacestat is an experimental drug that can be used with SEA-BCMA to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
305 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 :
Jan 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: SEA-BCMA Monotherapy

SEA-BCMA

Drug: SEA-BCMA
Given into the vein (IV; intravenously)

Experimental: 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: 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

Experimental: SEA-BCMA + Nirogacestat + Dexamethasone Combination Therapy

SEA-BCMA + dexamethasone + nirogacestat

Drug: SEA-BCMA
Given into the vein (IV; intravenously)

Drug: dexamethasone
Given by mouth (orally) or by IV

Drug: nirogacestat
Given orally

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  3. Incidence of dose-limiting toxicities (DLTs) [Through up to 28 days following first dose]

    To be summarized using descriptive statistics.

Secondary Outcome Measures

  1. 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.

  2. PK outcome: AUC (area under the serum concentration-time curve) [Through 84 days following first dose]

    To be summarized using descriptive statistics.

  3. Incidence of SEA-BCMA antitherapeutic antibodies (ATA) [Through 30-37 days following last dose, up to approximately 4 years]

  4. Best response per the IMWG uniform response criteria [Up to approximately 5 years]

    International Myeloma Working Group (IMWG)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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:
No
Inclusion Criteria:
  • Histologically confirmed diagnosis of MM

  • Must have MM that is relapsed or refractory

  • Parts A, B, C, and E: Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody

  • Part D only: Has received 2 prior lines of therapy and has not previously received pomalidomide

  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Stanford University School of MedicinePalo AltoCaliforniaUnited States94304
2Rocky Mountain Cancer Centers - AuroraAuroraColoradoUnited States80012
3University of MiamiMiamiFloridaUnited States33136
4Holden Comprehensive Cancer Center / University of IowaIowa CityIowaUnited States52242
5University of Kansas Cancer CenterWestwoodKansasUnited States66205
6Washington University in St LouisSaint LouisMissouriUnited States63110
7Weill Cornell MedicineNew YorkNew YorkUnited States10065
8James P. Wilmot Cancer Center / University of Rochester Medical CenterRochesterNew YorkUnited States14642
9Willamette Valley Cancer Institute/Oncology Assc of OregonEugeneOregonUnited States97401
10Texas Oncology - Austin MidtownAustinTexasUnited States78705
11Fred Hutchinson Cancer Research CenterSeattleWashingtonUnited States98109-1024

Sponsors and Collaborators

  • Seagen Inc.

Investigators

  • Study Director: Phoenix Ho, MD, Seagen Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seagen Inc.
ClinicalTrials.gov Identifier:
NCT03582033
Other Study ID Numbers:
  • SGNBCMA-001
First Posted:
Jul 10, 2018
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seagen Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021