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JOURNAL ONKOLOGIE – STUDIE

A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma

Rekrutierend

NCT-Nummer:
NCT06153251

Studienbeginn:
Januar 2024

Letztes Update:
26.02.2024

Wirkstoff:
BMS-986453, Fludarabine, Cyclophosphamide

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Collaborator:
-

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

BMS Study Connect www.BMSStudyConnect.com
Kontakt:
Phone: 855-907-3286
E-Mail: Clinical.Trials@bms.com» Kontaktdaten anzeigen
First line of the email MUST contain the NCT# and Site#

Studienlocations
(3 von 17)

Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to assess BMS-986453 in participants with relapsed and/or

refractory multiple myeloma (RRMM).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory

disease.

- Participants must have confirmed progressive disease on or within 12 months (measured

from the last dose) of completing treatment with the last anti-myeloma treatment

regimen before study entry.

- Participants in Part A and Part B Cohort 1 must have received at least 3 prior

anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory

agent.

- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status

of 0 or 1.

- Participants must have adequate organ function.

Exclusion Criteria:

- Participants must not have any known active or history of central nervous system (CNS)

involvement of multiple myeloma.

- Participants must not have active or history of plasma cell leukemia, Waldenstrom's

macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal

protein, skin changes) syndrome, or clinically significant amyloidosis.

- Participants must not have a history or presence of clinically significant CNS

pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia,

Parkinson's disease, or cerebellar disease, or presence of clinically active

psychosis.

Other protocol-defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Number of participants with treatment-emergent adverse events (AEs) (Time Frame - Up to 2 years)

2. Number of participants with serious adverse events (SAEs) (Time Frame - Up to 2 years)

3. Number of participants with AEs leading to discontinuation (Time Frame - Up to 2 years)

4. Number of participants with AEs leading to death (Time Frame - Up to 2 years)

5. Number of participants with dose-limiting toxicities (DLTs) (Time Frame - Up to 2 years)

Secondary outcome:

1. Maximum observed concentration (Cmax) (Time Frame - Up to 2 years)

2. Time of maximum observed concentration (Tmax) (Time Frame - Up to 2 years)

3. Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D)) (Time Frame - Up to 2 years)

4. Overall response rate (ORR) (Time Frame - Up to 2 years)

5. Complete response rate (CRR) (Time Frame - Up to 2 years)

6. Number of participants with very good partial response (VGPR) or better (Time Frame - Up to 2 years)

7. Progression-free survival (PFS) (Time Frame - Up to 2 years)

8. Overall survival (OS) (Time Frame - Up to 2 years)

9. Time to response (TTR) (Time Frame - Up to 2 years)

10. Time to complete response (TTCR) (Time Frame - Up to 2 years)

11. Duration of response (DOR) (Time Frame - Up to 2 years)

12. Duration of complete response (DOCR) (Time Frame - Up to 2 years)

13. Persistence of BMS-986453 in peripheral blood (Time Frame - Up to 2 years):
Defined as a transgene count greater than or equal to the lower limit of detection (LLOD)

14. Expansion rate (Time Frame - Up to 2 years):
Defined as Cmax divided by Tmax

Geprüfte Regime

  • BMS-986453:
    Specified dose on specified days
  • Fludarabine:
    Specified dose on specified days
  • Cyclophosphamide:
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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