A Study to Evaluate Adverse Events, Change in Disease Activity, Tolerability, and How Intravenous ABBV-438 Moves Through the Body in Adult Participants With Multiple Myeloma (MM)

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT07409246
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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, tolerability, and how ABBV-438 moves through the body, in adult participants with relapsed/refractory (R/R) MM. Adverse events, tolerability, how ABBV-438 moves through the body will be assessed. ABBV-438 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms broken into 2 parts. ABBV-438 will be given alone and multiple doses will be explored. This study will include a dose escalation phase (Part 1) to determine the best dose of ABBV-438, followed by a dose expansion phase (Part 2) to confirm the dose. Approximately 127 adult participants with R/R MM will be enrolled in the study in approximately 24 sites worldwide. Participants will receive intravenous (IV) ABBV-438 alone first in multiple doses in the dose escalation phase (Part 1); then in 1 of 2 doses from Part 1 in the dose expansion phase (Part 2). The overall study duration will be approximately 69.5 months. 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, questionnaires and side effects.

Key Dates

Start date
Feb 27, 2026
Status verified
May 2026
Primary completion
Nov 30, 2031
Completion
Nov 30, 2031

Study Design

Enrollment
127 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: ABBV-438 Monotherapy Dose Escalation
    Participants will receive ABBV-438 in escalating doses alone, as part of the 69.5 study duration.
  • Experimental: Part 2: ABBV-438 Monotherapy Dose Expansion (Dose A)
    Participants will receive ABBV-438 Dose A alone, as part of the 69.5 study duration.
  • Experimental: Part 2: ABBV-438 Monotherapy Dose Expansion (Dose B)
    Participants will receive ABBV-438 Dose B alone, as part of the 69.5 study duration.

Primary Outcome Measure

Number of Participants With Adverse Events (AE) [ Time Frame: Up to Approximately 69.5 Months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center /ID# 280273DuarteCalifornia91010-
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 279067IrvineCalifornia92618-
Colorado Blood Cancer Institute /ID# 280275DenverColorado80218-
City Of Hope - Atlanta. /ID# 280294NewnanGeorgia30265-
START Midwest /ID# 279035Grand RapidsMichigan49546-

Find similar trials in Duarte, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
City of Hope National Medical Center· Duarte, CACity of Hope - Orange County Lennar Foundation Cancer Center· Irvine, CAColorado Blood Cancer Institute· Denver, COCity Of Hope - Atlanta.· Newnan, GASTART Midwest· Grand Rapids, MI

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