JOURNAL ONKOLOGIE – STUDIE

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05308654

Studienbeginn:
Mai 2022

Letztes Update:
25.01.2024

Wirkstoff:
ABBV-453, Dexamethasone, Daratumumab, Lenalidomide

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
AbbVie

Collaborator:
-

Studienleiter

ABBVIE INC.
Study Director
AbbVie

Kontakt

ABBVIE CALL CENTER
Kontakt:
Phone: 844-663-3742
E-Mail: abbvieclinicaltrials@abbvie.com» Kontaktdaten anzeigen

Studienlocations
(3 von 21)

Stanford University School of Med /ID# 242809
94305-2200 Stanford
United StatesRekrutierend» Google-Maps

Sylvester Comprehensive Cancer Center /ID# 243417
33136-1002 Miami
United StatesRekrutierend» Google-Maps

Tulane University /ID# 244854
70112-2699 New Orleans
United StatesRekrutierend» Google-Maps

American Oncology Partners of Maryland, PA /ID# 244858
20817 Bethesda
United StatesRekrutierend» Google-Maps

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 242754
48109 Ann Arbor
United StatesRekrutierend» Google-Maps

Mayo Clinic - Rochester /ID# 242844
55905-0001 Rochester
United StatesRekrutierend» Google-Maps

Memorial Sloan Kettering Cancer Center /ID# 243503
10065-6007 New York
United StatesRekrutierend» Google-Maps

Univ NC Chapel Hill /ID# 243420
27514-4220 Chapel Hill
United StatesRekrutierend» Google-Maps

Duke Univ Med Ctr /ID# 242808
27710 Durham
United StatesRekrutierend» Google-Maps

Wake Forest Baptist Health /ID# 244252
27157-0001 Winston-Salem
United StatesRekrutierend» Google-Maps

Penn Presbyterian Medical Center /ID# 242842
19104-2640 Philadelphia
United StatesRekrutierend» Google-Maps

Vanderbilt Ingram Cancer Center /ID# 242810
37232-0021 Nashville
United StatesRekrutierend» Google-Maps

Liverpool Hospital /ID# 244826
2170 Liverpool
AustraliaRekrutierend» Google-Maps

St Vincent's Hospital Melbourne /ID# 244827
3065 Fitzroy Melbourne
AustraliaRekrutierend» Google-Maps

St. Vincent's Private Hospital Melbourne /ID# 262631
3065 Fitzroy
AustraliaRekrutierend» Google-Maps

Austin Health and Ludwig Institute for Cancer Research /ID# 248311
3084 Heidelberg
AustraliaRekrutierend» Google-Maps

Epworth Healthcare /ID# 248705
3121 Richmond
AustraliaRekrutierend» Google-Maps

The Chaim Sheba Medical Center /ID# 250482
5265601 Ramat Gan
IsraelRekrutierend» Google-Maps

Tel Aviv Sourasky Medical Center /ID# 250483
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps

Hadassah Medical Center-Hebrew University /ID# 250484
91120 Jerusalem
IsraelRekrutierend» Google-Maps

Barts Health NHS Trust /ID# 248972
E1 2ES London
United KingdomRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Brief Summary:

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma

cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of

ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change

in disease activity will be assessed.

ABBV-453 is an investigational drug being developed for the treatment of R/R MM. Part 1 will

be a monotherapy dose escalation phase to determine the best dose of ABBV-453. In Part 2,

participants are placed in 1 of 3 groups called treatment arms. Each group receives a

different treatment. Approximately 28 to 48 adult participants in Part 1 and 150 to 312 adult

participants in Part 2 with R/R MM will be enrolled in the study in approximately 70 sites

worldwide.

In Part 1 and the Japan Cohort, Participants will receive oral ABBV-453 tablets once daily

(QD) in 28-day cycles. In Part 2, Arm 1, participants will receive continuous doses of oral

ABBV-453 tablets QD in combination with oral dexamethasone tablets once weekly in 28-day

cycles. In Part 2, Arm 2, participants will receive continuous doses of oral ABBV-453 tablets

QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks and oral

dexamethasone tablets once weekly in, 28-day cycles. In Part 2, Arm 3, participants will

receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous

injections of daratumumab every 1 to 4 weeks, oral lenalidomide capsules QD on Days 1-21, and

oral dexamethasone tablets once weekly, in 28-day cycles.

There may be higher treatment burden for participants in this trial compared to their

standard of care. Participants will attend regular visits during the study at an approved

institution (hospital or clinic). The effect of the treatment will be frequently checked by

medical assessments, blood tests, and side effects.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status <= 1.

- Laboratory values meeting the criteria outlined in the protocol.

- Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma

Working Group (IMWG) criteria.

- Has measurable disease at screening as defined in the protocol.

- Locally documented or centrally determined t(11;14) positive status and/or centrally

determined BCL2high status. Note: If local testing for t(11;14) is discordant with

central testing for t(11;14) status, a detailed review of central and local results

for t(11;14) status is required to ensure the participants' safety.

- Part 1 and Part 2, Arm 1 Only: Refractory to or intolerant of all established MM

therapies that are known to provide clinical benefit and are triple class exposed to a

proteasome inhibitors (PI), an Immunomodulatory drugs (IMID), and an anti-CD38

monoclonal antibody in previous line(s) of therapy.

- Part 2, Arms 2 and 3 Only: Received 1 to 3 prior lines of therapy, including a PI or

an IMiD.

- Part 1 only: Permitted to be venetoclax or BCL-2 inhibitor exposed in previous lines

of therapy.

- Life expectancy >= 12 weeks.

Exclusion Criteria:

- Clinically relevant or significant Electrocardiogram (ECG) abnormalities as outlined

in the protocol.

- Part 2 only: Previous treatment with venetoclax or BCL-2 inhibitor.

- Part 2, Arms 2 and 3 only: Prior daratumumab or other anti-CD38 therapy exposure that

meets any of the criteria outlined in the protocol.

Studien-Rationale

Primary outcome:

1. Overall Response Rate (ORR) per International Myeloma Working Group (IMWG) Criteria (Time Frame - Up to Approximately 12 Months):
ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) + very good partial response (VGPR) + complete response (CR) + stringent complete response (sCR) as assessed by investigators per adapted IMWG criteria for relapsed or refractory (R/R) multiple myeloma (MM).

Secondary outcome:

1. Duration of Response (DOR) (Time Frame - Up to Approximately 24 Months):
DOR is defined for participants achieving a confirmed sCR/CR/VGPR/PR as the time from the initial response of sCR/CR/VGPR/PR per investigator review according to adapted IMWG criteria to disease progression or death of any cause, whichever occurs earlier.

2. Depth of Response Minimal Residual Disease (MRD) (Time Frame - Up to Approximately 24 Months):
MRD negativity is defined as having less than 1 myeloma cell that may remain in the bone marrow aspirate. Depth of response is defined as the proportion of MRD negativity for participants achieving a confirmed sCR/CR per investigator review according to IMWG criteria.

3. Progression Free Survival (PFS) (Time Frame - Up to Approximately 36 Months):
PFS is defined as time from first study treatment to a documented disease progression according to adapted IMWG criteria, as determined by the investigator, or death due to any cause, whichever occurs earlier.

4. Overall Survival (OS) (Time Frame - Up to Approximately 36 Months):
Overall survival (OS) is defined as time from first study treatment to death due to any cause.

Studien-Arme

Experimental: Part 1: Monotherapy Dose Escalation
Participants with relapsed or refractory (R/R) multiple myeloma (MM) will receive escalating doses of ABBV-453, until the maximum tolerated dose (MTD) is determined.
Experimental: Part 2: Arm 1
Participants will receive continuous doses of ABBV-453 in combination with dexamethasone in 28-day cycles.
Experimental: Part 2: Arm 2
Participants will receive continuous doses of ABBV-453 in combination with daratumumab and dexamethasone in 28-day cycles.
Experimental: Part 2: Arm 3
Participants will receive continuous doses of ABBV-453 in combination with daratumumab, lenalidomide, and dexamethasone in 28-day cycles.
Experimental: Japan Cohort
Participants with R/R MM will receive escalating doses of ABBV-453, until the MTD is determined.

Geprüfte Regime

ABBV-453:
Oral; Tablet
Dexamethasone:
Oral Tablet
Daratumumab:
Subcutaneous Injection
Lenalidomide:
Oral Capsule

Quelle: ClinicalTrials.gov

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