R/R Multiple Myeloma MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Venclyxto
Product Name: Venetoclax
Product Code: ABT-199 (GDC-0199)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Venetoclax
Current Sponsor code: ABT-199 (GDC-0199)
Concent
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male of female, at least 18 years old • R/R MM with documented evidence of progression during or after the subject's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria • Measurable disease, defined by at least 1 of the following disease activity criteria: - serum M-protein = 1.0 g/dL (= 10 g/L) for immunoglobulin (Ig)G MM - serum M-protein = 0.5 g/dL (= 5 g/L) for IgA, IgD, IgE, and IgM MM - urine M-protein = 200 mg/24 hours - serum-free light chain (FLC) = 10 mg/dL provided serum FLC ratio is abnormal • Has received at least 1 prior line of therapy • Must meet all of the following prior antimyeloma treatment parameters: - subject must have received at least 2 consecutive cycles of lenalidomide or a lenalidomide-containing regimen - subject must be refractory to lenalidomide - subject must have been exposed to a proteasome inhibitor alone or in combination with another agent - subject must have had a response of PR or better to prior therapy based on the investigator's determination of response as defined by IMWG criteria • Has t(11;14) status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per central laboratory testing of a bone marrow aspirate sample and meets the following criteria: - For Part 1: MM subjects independent of cytogenetic profile - For Part 2, Arm A: subject must be t(11;14) positive - For Part 2, Arm B: subject must be t(11;14) negative • (ECOG) performance status = 2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • previous treatment with venetoclax or other BCL-2 inhibitors, or previous treatment with pomalidomide • known sensitivity to any IMiDs • allogenic or syngeneic stem cell transplant within 6 months before the first dose of study drug or active ongoing graft versus host disease • autologous stem cell transplant within 12 weeks before the first dose of study drug • known meningeal involvement of MM
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the safety and tolerability profiles of venetoclax combined with pomalidomide and dexamethasone when co-administered in subjects with R/R MM;Secondary Objective: -To evaluate the anti-MM activity of co-administered venetoclax combined with pomalidomide and dexamethasone when co-administered in subjects with R/R MM -To characterize the plasma pharmaacokinetics (PK) of venetoclax and pomalidomide when co-administered in subjects with R/R MM;Primary end point(s): Overall Response Rate;Timepoint(s) of evaluation of this end point: Dependent on individual subjects response to therapy. All subjects with be treated until progressive disease, unacceptable toxicity, or other reason for discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Secondary Endpoints are: • Progression-free survival (PFS) • Duration of response (DOR) • Time-to-progression (TTP;Timepoint(s) of evaluation of this end point: Will be monitored throughout the subject's participation in the study. | — |
Countries
Spain, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed