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JOURNAL ONKOLOGIE – STUDIE

Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma

Rekrutierend

NCT-Nummer:
NCT03486067

Studienbeginn:
April 2018

Letztes Update:
10.04.2024

Wirkstoff:
CC-93269

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

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 37)

Local Institution - 0506
81829 Munich
(Bayern)
GermanyZurückgezogen» Google-Maps
Local Institution - 0507
81829 Munich
(Bayern)
GermanyZurückgezogen» Google-Maps
Henry Ford Medical Center - New Center One
48202 Detroit
United StatesAbgeschlossen» Google-Maps
Icahn School of Medicine at Mount Sinai Mount Sinai West
10019 New York
United StatesAbgeschlossen» Google-Maps
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Ansprechpartner:
Maria-Victoria Mateos Manteca, Site 203» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C

subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses

of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and

non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further

evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in

selected expansion cohorts of up to approximately 20 evaluable subjects each in order to

determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for

cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for

subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable

toxicity, or subject/investigator decision to withdraw.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- History of multiple myeloma with relapsed and refractory disease

- Eastern Cooperative Oncology Group Performance Status of 0 or 1

- Must have measurable disease as determined by the central laboratory

Exclusion Criteria:

- Symptomatic central nervous system involvement of multiple myeloma

- Prior autologous stem cell transplant ≤ 3 months prior

- Prior allogeneic stem cell transplant with either standard or reduced intensity

conditioning ≤ 12 months prior

- History of concurrent second cancers requiring active, ongoing systemic treatment

Other protocol-defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Adverse Events (AEs) (Time Frame - Up to approximately 63 months):
Number of participants with Adverse Events

2. Dose Limiting Toxicity (DLT) (Time Frame - Up to 60 months):
Is defined as any of the toxicities occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to extraneous causes.

3. Non-Tolerated Dose (NTD) (Time Frame - Up to 60 months):
Is defined as a dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in the DLT window.

4. Maximum Tolerated Dose (MTD) (Time Frame - Up to 60 months):
Is defined as the last dose cohort below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during the DLT window.

Secondary outcome:

1. Overall Response Rate (ORR) (Time Frame - Up to 60 months):
Is defined as the proportion of subjects who achieve a partial response or better (eg, PR, VGPR, CR or sCR), according to International Myeloma Working Group (IMWG) response criteria.

2. Time to Response (Time Frame - Up to 60 months):
Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).

3. Duration of Response (Time Frame - Up to 60 months):
Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.

4. Progression Free Survival (Time Frame - Up to 60 months):
Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.

5. Overall Survival (Time Frame - Up to 60 months):
Is defined as the time from the first dose of CC-93269 to death from any cause.

6. Pharmacokinetics - Cmax (Time Frame - Up to 60 months):
Maximum serum concentration of drug

7. Pharmacokinetics - Cmin (Time Frame - Up to 60 months):
Minimum serum concentration of drug

8. Pharmacokinetics - AUC (Time Frame - Up to 60 months):
Area under the curve

9. Pharmacokinetics - tmax (Time Frame - Up to 60 months):
Time to peak (maximum) serum concentration

10. Pharmacokinetics - t1/2 (Time Frame - Up to 60 months):
Terminal Half-life

11. Pharmacokinetics - CL (Time Frame - Up to 60 months):
Apparent total body clearance

12. Pharmacokinetics - Vss (Time Frame - Up to 60 months):
Volume of distribution at steady-state

13. Pharmacokinetics - accumulation index of alnuctamab (Time Frame - Up to 60 months):
Accumulation ratio of drug

14. Presence and frequency of anti-drug antibodies (ADA) (Time Frame - Up to 60 months):
Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies

Geprüfte Regime

  • CC-93269 (Alnuctamab):
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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