Relapsed or Refractory Multiple Myeloma MedDRA version: 16.1 Level: HLT Classification code 10028229 Term: Multiple myelomas System Organ Class: 100000004851
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status = 2. 2. Subject has documented relapsed or progressive multiple myeloma on or after any regimen or is refractory to the most recent line of therapy. ? Relapsed myeloma is defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet the criteria for refractory myeloma. ? Refractory myeloma is defined as disease that is nonresponsive (failure to achieve minimal response or development of PD) while on primary or salvage therapy, or progresses within 60 days of last therapy. 3. Subject must have received prior treatment with at least one, but no more than three, prior lines of therapy for multiple myeloma. ? A line of therapy consists of = 1 complete cycle of a single agent, a regimen consisting of combination of several drugs, or a planned sequential therapy of various regimens. 4. Prior treatment with bortezomib or other proteasome inhibitor is allowed, provided ALL of the following criteria are met: ? Disease is NOT refractory to any proteasome inhibitor, defined as no disease progression (i.e., PD, per IMWG or European Society for Blood and Marrow Transplantation [EBMT] criteria) while receiving proteasome inhibitor therapy or within 60 days after the last dose, AND ? Best response achieved with any proteasome inhibitor therapy (alone or in combination) was at least a PR, AND ? Subject did not discontinue any proteasome inhibitor due to intolerance or = Grade 3 related toxicity. 5. Subject has measurable disease at Screening, defined as at least one of the following: ? Serum M-protein = 0.5 g/dL, OR ? Urine M-protein = 200 mg in 24-hours, OR ? Serum immunoglobulin free light chain (FLC) = 10 mg/dL provided serum FLC ratio is abnormal. 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 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: 1. Subject is refractory to any proteasome inhibitor, defined as progression on or within 60 days of the last dose of a proteasome inhibitor-containing regimen. 2. Subject has had prior treatment with proteasome inhibitor within 60 days prior to first dose of study drug. 3. Subject has any of the following conditions: ? Non-secretory multiple myeloma ? Active plasma cell leukemia i.e., either 20% of peripheral white blood cells comprised of plasma cells or > 2.0 × 10^9/liter (L) circulating plasma cells by standard differential ? Waldenström's macroglobulinemia ? Amyloidosis ? POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) ? Known Human Immunodeficiency Viral (HIV) infection ? Active hepatitis B or C infection based on screening blood testing ? Significant cardiovascular disease, including uncontrolled angina, severe or uncontrolled arrhythmia, recent myocardial infarction within 6 months of randomization, or congestive heart failure New York Heart Association (NYHA) Class = 3 ? Major surgery within 4 weeks prior to randomization ? Acute infections requiring parenteral therapy (antibiotic, antifungal, or antiviral) within 14 days prior to randomization ? Peripheral neuropathy = Grade 3 or = Grade 2 with pain within 2 weeks prior to randomization ? Uncontrolled diabetes or uncontrolled hypertension within 14 days prior to randomization ? Any other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study 4. Subject has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with the following exceptions: ? Adequately treated in situ carcinoma of the cervix uteri or the breast ? Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin ? Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment ? Previous malignancy with no evidence of disease, confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study 5. If subject had prior stem cell transplant (SCT), subject has evidence of ongoing graft-versus-host disease (GvHD).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression Free Survival ;Secondary Objective: - Overall Survival - Very Good Partial Response or better response rate - Progression Free Survival in subjects with high BLC2 expression - Duration of response - Patient Reported Outcomes - Time to Progression - Overall Response Rate - Minimal Residual Disease Status - Safety;Primary end point(s): Progression Free Survival ;Timepoint(s) of evaluation of this end point: When 136 Progression Free Survival events occur | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival Very Good Partial Response or better response rate Progression Free Survival in subjects with high BLC2 expression Duration of response Patient Reported Outcomes Time to Progression Overall Response Rate Minimal Residual Disease Status;Timepoint(s) of evaluation of this end point: Overall Survival: when approximately 116 OS events are observed. Other secondary endpoints will be evaluated in the final analyses, following positive analysis for Progression Free Survival. | — |
Countries
Australia, Brazil, Canada, France, Germany, Hungary, Ireland, Italy, Japan, Korea, Republic of, Russian Federation, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed