An Open Label, Multicenter Phase 2 Study of Single-Agent Enzastaurin HCl in Previously Treated Waldenstrom’s Macroglobulinemia or Multiple Myeloma - N/A
- Conditions
- Waldenstrom’s Macroglobulinemia or Multiple Myeloma
- Registration Number
- EUCTR2008-000748-14-FR
- Lead Sponsor
- Eli Lilly and Company limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 46
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method