Multiple myeloma Multiple myeloma
Conditions
Interventions
Study M25-025 is a Phase 1 FIH, open-label, dose escalation and dose expansion study of ABBV-438 evaluating the safety, tolerability, PK, and preliminary efficacy in subjects with R/R MM. Study M25-02
Sponsors
Isshiki Yusuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Has relapsed or refractory Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the standard InternationalMyeloma Working Group (IMWG) (2016) response criteria: - Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy; - Refractory defined as disease that is nonresponsive (failure to achieve minimal response) while on last therapy, or progresses within 60 days of last therapy. - Has measurable disease at screening, defined by at least 1 of the following within 28 days prior to enrollment: - Serum M-protein >= 0.5 g/dL (>=5 g/L); OR; - Urine M-protein >= 200 mg/24 hours; OR; - Involved serum free light chain (sFLC) >= 10 mg/dL (100mg/L), provided serum FLC ratio is abnormal; - Must have had 3 or more prior lines of therapy with exposure to a proteasome inhibitor (PI), an immunomodulatory imide drugs (IMiD), and an anti-CD38 therapy and are intolerant to, or unable to access, available therapies that are known to confer clinical benefit to participants with relapsed or refractory (R/R) MM. Note: A line of therapy consists of relapsed or refractory 1 complete cycle of a single agent, a regimen consisting of a combination of several drugs, or a planned sequential therapy of various regimens.
Exclusion criteria
Exclusion criteria: - Known history of Central Nervous System involvement by MM. - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety will be evaluated based upon the assessment of all grade adverse events (AEs), serious AEs (SAEs) reported during the treatment-emergent AE (TEAE) period; clinical laboratory parameters (e.g., hematology, chemistry), vital sign measurements, and electrocardiogram (ECG) results. | — |
Secondary
| Measure | Time frame |
|---|---|
| The key efficacy endpoint is achievement of partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) as assessed by investigators per International Myeloma Working Group (IMWG) 2016 criteria Additional efficacy endpoints: - Achievement of VGPR or better - Duration of response (DOR) in subjects who achieved PR, VGPR, CR or sCR - Progression-free survival (PFS) Overall Survival (OS) - Minimal residual disease (MRD) negativity - Pharmacokinetic (PK) parameters, including the area under the serum/plasma concentration-time curve (AUC), maximum observed serum (or plasma, for payload) concentration (Cmax), the time to Cmax (Tmax), and half-life (t1/2), for ABBV-438, will be determined using noncompartmental methods for ABBV-438 conjugate (ADC), total antibody, and unconjugated GRM payload (A-1647462) as applicable. Anti-drug antibodies (ADAs) will be determined, and neutralizing antibodies (nAbs) may be determined, as appropriate. Additional parameters may be calculated and/or analyses may be conducted if appropriate and useful in data interpretation. | — |
Countries
America, Israel, Japan
Contacts
Public ContactContact for Patients and HCP
AbbVie G.K.
Outcome results
None listed