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JOURNAL ONKOLOGIE – STUDIE

A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

Rekrutierend

NCT-Nummer:
NCT03989414

Studienbeginn:
September 2019

Letztes Update:
10.01.2024

Wirkstoff:
CC-92480, Bortezomib, Dexamethasone, Daratumumab, Carfilzomib, Elotuzumab, Isatuximab

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Celgene

Collaborator:
-

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

BMS Study Connect Contact Center 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 50)

Local Institution - 606
12203 Berlin
(Berlin)
GermanyZurückgezogen» Google-Maps
Local Institution - 605
20246 Hamburg
(Hamburg)
GermanyAbgeschlossen» Google-Maps
Local Institution - 602
81675 Munchen
(Bayern)
GermanyAbgeschlossen» Google-Maps
Local Institution - 119
80218 Denver
United StatesAbgeschlossen» Google-Maps
Local Institution - 104
33612 Tampa
United StatesAbgeschlossen» Google-Maps
Local Institution - 112
60611 Chicago
United StatesAbgeschlossen» Google-Maps
Local Institution - 107
60637 Chicago
United StatesAbgeschlossen» Google-Maps
Local Institution - 106
55905 Rochester
United StatesAbgeschlossen» Google-Maps
Hackensack University Medical Center
07601 Hackensack
United StatesAbgeschlossen» Google-Maps
Local Institution - 110
27157 Winston-Salem
United StatesAbgeschlossen» Google-Maps
Local Institution - 114
37203 Nashville
United StatesAbgeschlossen» Google-Maps
Swedish Cancer Institute
98104 Seattle
United StatesAbgeschlossen» Google-Maps
Local Institution - 801
708 52 Ostrava-Poruba
CzechiaAbgeschlossen» Google-Maps
Local Institution - 403
42100 Reggio Emilia
ItalyAbgeschlossen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in

combination with standard treatments.

Ein-/Ausschlusskriterien

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2

For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will

also apply:

- Documented diagnosis of multiple myeloma (MM) and measurable disease

- Documented disease progression during or after their last antimyeloma regimen

- Achieved a response (minimal response [MR] or better) to at least 1 prior treatment

regimen

Exclusion Criteria:

- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy,

organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically

significant amyloidosis

- Known central nervous system (CNS) involvement with myeloma

- Received immunosuppressive medication within the last 14 days of initiating study

treatment

- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment

Other protocol-defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Recommended Dose (Time Frame - Up to approximately 3 years)

2. Recommended regimen as measured by dose-limiting toxicities (Time Frame - Up to approximately 3 years)

3. Number of participants with Adverse Events (AEs) (Time Frame - From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years)

4. Overall response rate (ORR) (Time Frame - Up to approximately 5 years)

Secondary outcome:

1. Time-to-response (TTR) (Time Frame - Up to approximately 5 years)

2. Duration of response (DOR) (Time Frame - Up to approximately 5 years)

3. Complete Response (CR) rate (Time Frame - Up to approximately 5 years)

4. Very good partial response (VGPR) rate - Cohorts D and E (Time Frame - Up to approximately 5 years)

Studien-Arme

  • Experimental: Cohort A: CC-92480 with bortezomib and dexamethasone
  • Experimental: Cohort C: CC-92480 with carfilzomib and dexamethasone
  • Experimental: Cohort H: CC-92480 with elotuzumab and dexamethasone
  • Experimental: Cohort I: CC-92480 with isatuximab and dexamethasone
  • Experimental: Cohort D: CC-92480 with bortezomib and dexamethasone
  • Experimental: Cohort F: CC-92480 with carfilzomib and dexamethasone
  • Experimental: Cohort J: CC-92480 with elotuzumab and dexamethasone
  • Experimental: Cohort K: CC-92480 with isatuximab and dexamethasone
  • Experimental: Cohort G: CC-92480 with bortezomib and dexamethasone
  • Experimental: Subcohort B1: CC-92480 with daratumumab and dexamethasone
  • Experimental: Subcohort B2: CC-92480 with daratumumab and dexamethasone
  • Experimental: Subcohort B3: CC-92480 with daratumumab and dexamethasone
  • Experimental: Subcohort E1: CC-92480 with daratumumab and dexamethasone
  • Experimental: Subcohort E2: CC-92480 with daratumumab and dexamethasone
  • Experimental: Subcohort E3: CC-92480 with daratumumab and dexamethasone

Geprüfte Regime

  • CC-92480 (BMS-986348 / mezigdomide / ):
    Specified dose on specified days
  • Bortezomib:
    Specified dose on specified days
  • Dexamethasone:
    Specified dose on specified days
  • Daratumumab:
    Specified dose on specified days
  • Carfilzomib:
    Specified dose on specified days
  • Elotuzumab:
    Specified dose on specified days
  • Isatuximab:
    Specified dose on specified days
  • Carfilzomib:
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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"A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)"

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