Waldenstrom’s Macroglobulinemia or Multiple Myeloma
Conditions
Sponsors
Eli Lilly and Company limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: [1] At least 18 years of age. [2] Patients must have WM or MM previously treated with at least 1 and no more than 5 prior therapies. [3] Treatment with prior autologous transplant is permitted. If a transplant is used as consolidation following chemotherapy, without intervening disease progression, it will be considered 1 line of treatment with the preceding chemotherapy. [4a] Patients with MM must have a monoclonal protein in the serum of =1 g/dL or monoclonal light chain in the urine protein electrophoresis of = 200 mg/ 24 hours, or measurable plasmacytoma. [4b] Patients with WM must have an immunoglobulin M (IgM) paraprotein with a minimum IgM level of = 2 times the upper limit of normal, have detectable lymphoplasmacytic (LPL) cells in the bone marrow, and be symptomatic for WM. [5] ECOG Performance Status (PS) of 0, 1, or 2. See Protocol Attachment S042.5. [6] The following laboratory values obtained prior to registration: • Absolute neutrophil count (ANC) =1000/ µL • Platelet (PLT) count =75,000/ µL • Total bilirubin = 1.5 x upper limit of normal (ULN) (if total is elevated check direct and, if normal, patient is eligible) • Aspartate transaminase (AST) = 3 x ULN • Creatinine =1.5 x ULN • Hemoglobin (Hgb) =8.0 g/dL. [7] Expected survival of >12 weeks. [8] The ability to provide informed consent. [9] Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment. Women with childbearing potential must have a negative serum pregnancy test = 3 days prior to study enrollment 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: [10] Prior allogeneic hematopoietic stem cell transplant. [11] Are unable to discontinue use of non-EIAEDs, for example carbamazepine, phenobarbital, and phenytoin (refer to Section 5.6). Patients on anti-coagulant therapy should be monitored (see Section 5.6.2). Ongoing treatment with therapeutic doses of Coumadin is prohibited. However, prophylactic, low dose (= 2mg daily) Coumadin for DVT is allowed. In such cases, PT/INR should be closely monitored. [12] Have ECG abnormalities including baseline 12-lead ECG with QTc interval of >450 msec in males or >470 msec in females, or QRS duration of >100 msec. Patients who have a congenital long-QT-syndrome in their own or family medical history should be excluded at the investigator’s discretion. [13] Have an uncontrolled infection. [14] Have prior treatment with BCNU = 6 weeks, alkylating agent = 4 weeks, or other cytotoxic chemotherapy agents = 4 weeks prior to registration in this trial. Have prior treatment with biologic therapy = 12 weeks or corticosteroids = 2 weeks prior to registration in this trial. However, treatment with = 10 mg of prednisone as a chronic therapy is allowed. [15] Have radiation therapy = 2 weeks prior to treatment in this trial. [16] Are pregnant or breast-feeding. [17] Are being treated with concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational. [18] Are known to be HIV positive. [19] Were previously treated with enzastaurin. [20] Patients who are unable to swallow tablets. [21] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [22] Concurrent malignancy that could complicate interpretation of response or safety evaluation. Non-melanoma skin cancer and carcinoma in situ of the cervix are not exclusions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether further study of single-agent enzastaurin is warranted in patients with previously treated WM or MM, based on RR. ;Secondary Objective: to estimate the RR in patients with previously treated WM and in patients with previously treated MM • to estimate the TTP in patients with either WM or MM treated with enzastaurin • to assess the safety of enzastaurin in WM and MM • to explore the impact of adding dexamethasone to enzastaurin in WM and MM patients with PD. • to assess exploratory biomarkers relevant to enzastaurin and disease state, and assess their relationship with clinical outcome. ;Primary end point(s): To determine whether further study of single-agent enzastaurin is warranted in patients with previously treated WM or MM, based on RR. | — |
Countries
France
Outcome results
None listed