Clinical trial · Interventional
Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
NCT02462525CI-TRIAL-00034839terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No Go decision for ABBV-838
Summary
Brief summary (as posted)
This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABBV-838 | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ABBV-838 dose escalation
- description
- Varying doses of ABBV-838
- interventionNames
- Drug: ABBV-838
- type
- EXPERIMENTAL
- label
- ABBV-838 plus pomalidomide/dexamethasone
- description
- ABBV-838 to be evaluated with pomalidomide/dexamethasone.
- interventionNames
- Drug: ABBV-838
- Drug: Pomalidomide
- Drug: Dexamethasone
Primary outcomes (2)
- measure
- Maximum plasma concentration (Cmax) of ABBV-838
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group Performance Status of 0 to 2 * Not eligible for stem cell/bone marrow transplant or have refused stem cell/bone marrow transplant or have relapsed after autologous or allogeneic stem cell/bone marrow transplant * Eligible for and agree to BM aspirate prior to treatment start * Measurable disease M component in serum (≥ 0.5 g/dL) and/or urine (≥ 0.2 g excreted in a 24 hour collection sample) * Must have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or those who are double refractory to a PI and an immunomodulatory agent and have demonstrated disease progression (DP) on or within 60 days of completion of the last therapy; participants previously treated with an alkylating agent, in addition to an IMiD or proteasome inhibitor, are allowed to enroll in the trial * Participants must have adequate liver, kidney, and bone morrow function * Participants with a history of chronic heart failure must have cardiac ECHO indicating left ventricular ejection fraction (LVEF) ≥ 45% within 21 days prior to first dose of study drug * Participants in the combination therapy arms must be eligible to receive pomalidomide/dexamethasone, bortezomib/dexamethasone or lenalidomide/dexamethasone or other approved agents per current prescribing information for MM. * Participants who will receive combination therapy with Pomalidomide/Dexamethasone must have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy Exclusion Criteria: * Received anti-cancer therapy including chemotherapy, immunotherapy, radiation, biologic, any investigational therapy or herbal therapy within a period of 21 days prior to the first dose of ABBV-838, and have unresolved toxicities ≥ grade 2 * Concurrent metastatic solid tumors * Non-Measurable M Protein (serum or urine) and measurable sFLC (\< 100 mg/mL) * Major surgery within 21 days prior to the first dose of ABBV-838 * Clinically significant uncontrolled condition(s) including but not limited to the following: Grade ≥ 3 peripheral neuropathy or grade 2 peripheral neuropathy with pain Uncontrolled hypercalcemia Active uncontrolled infection Symptomatic congestive heart failure Unstable angina pectoris or cardiac arrhythmia Psychiatric illness/social situation that would limit compliance with the study * Major immunologic reaction to any IgG containing agent or auristatin based agent * Participants who are taking strong CYP3A4 inhibitors * Positive for HIV (Human Immunodeficiency Virus) or with active hepatitis B and/or C * Corneal pathology that would limit evaluation of loss in visual acuity associated with corneal deposits. * Prior exposure to pomalidomide for subjects enrolling in the pomalidomide/dexamethasone combination arm.
References
Publications (1)
- DERIVEDVij R, Nath R, Afar DEH, Mateos MV, Berdeja JG, Raab MS, Guenther A, Martinez-Lopez J, Jakubowiak AJ, Leleu X, Weisel K, Wong S, Gulbranson S, Sheridan JP, Reddy A, Paiva B, Singhal A, San-Miguel JF, Moreau P. First-in-Human Phase I Study of ABBV-838, an Antibody-Drug Conjugate Targeting SLAMF7/CS1 in Patients with Relapsed and Refractory Multiple Myeloma. Clin Cancer Res. 2020 May 15;26(10):2308-2317. doi: 10.1158/1078-0432.CCR-19-1431. Epub 2020 Jan 22. PMID 31969330