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A Study for Patients That Have Been Previously Been Treated in Waldenstrom's Macroglobulinemia or Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00718419
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : September 11, 2012
Information provided by (Responsible Party):

July 16, 2008
July 18, 2008
September 11, 2012
July 2008
September 2010   (Final data collection date for primary outcome measure)
Response Rate [ Time Frame: Baseline to measured progressive disease ]
Same as current
Complete list of historical versions of study NCT00718419 on ClinicalTrials.gov Archive Site
  • Duration of response [ Time Frame: time of response to progressive disease ]
  • Time to progressive disease [ Time Frame: baseline to measured progressive disease ]
  • Safety and Adverse Events [ Time Frame: every cycle ]
Same as current
Not Provided
Not Provided
A Study for Patients That Have Been Previously Been Treated in Waldenstrom's Macroglobulinemia or Multiple Myeloma
An Open Label, Multicenter Phase 2 Study of Single-Agent Enzastaurin HCl in Previously Treated Waldenstrom's Macroglobulinemia or Multiple Myeloma
To determine whether further study of single-agent enzastaurin is warranted in patients with previously treated Waldenstrom's Macroglobulinemia or Multiple Myeloma based on response.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Waldenstrom's Macroglobulinemia
  • Multiple Myeloma
Drug: Enzastaurin
Enzastaurin: Cycle 1 Day 1 only: 3, 125-mg tablets three times on Day 1 (Day 1 total dose = 1125 mg) Day 2 onwards and subsequent Cycles: 2, 125-mg tablets orally BID (500 mg total per day) Cycle length (all cycles): 28 Days Patients may stay on drug past 8 cycles, (until the study is closed) or until disease progression.
Other Name: LY317615
Experimental: A
Intervention: Drug: Enzastaurin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2012
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 18 years of age.
  • Patients must have WM or MM previously treated with at least 1 and no more than 5 prior therapies.
  • 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.
  • Patients with MM must have a monoclonal protein in the serum of greater than or equal to 1 g/dL or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200 mg/ 24 hours, or measurable plasmacytoma.
  • 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.
  • ECOG Performance Status (PS) of 0, 1, or 2.
  • The following laboratory values obtained prior to registration:

    • Absolute neutrophil count (ANC) greater than or equal to 1000/microL
    • Platelet (PLT) count greater than or equal to 75,000/microL
    • Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (if total is elevated check direct and, if normal, patient is eligible)
    • Aspartate transaminase (AST) less than or equal to 3 x ULN
    • Creatinine less than or equal to 1.5 x ULN
    • Hemoglobin (Hgb) greater than or equal to 8.0 g/dL.
  • Expected survival of greater than 12 weeks.
  • The ability to provide informed consent.
  • 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 less than or equal to 3 days prior to study enrollment

Exclusion Criteria:

  • Prior allogeneic hematopoietic stem cell transplant.
  • Are unable to discontinue use of non-EIAEDs, for example carbamazepine, phenobarbital, and phenytoin. Patients on anti-coagulant therapy should be monitored. Ongoing treatment with therapeutic doses of Coumadin is prohibited. However, prophylactic, low dose (less than or equal to 2mg daily) Coumadin for DVT is allowed. In such cases, PT/INR should be closely monitored.
  • Have ECG abnormalities including baseline 12-lead ECG with QTc interval of greater than 450 msec in males or greater than 470 msec in females, or QRS duration of greater than 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.
  • Have an uncontrolled infection.
  • 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 less than or equal to 12 weeks or corticosteroids less than or equal to 2 weeks prior to registration in this trial. However, treatment with less than or equal to 10 mg of prednisone as a chronic therapy is allowed.
  • Have radiation therapy less than or equal to 2 weeks prior to treatment in this trial.
  • Are pregnant or breast-feeding.
  • Are being treated with concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational.
  • Are known to be HIV positive.
  • Were previously treated with enzastaurin.
  • Patients who are unable to swallow tablets.
  • 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.
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
France,   United States
H6Q-MC-S042 ( Other Identifier: Eli Lilly and Company )
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- Fri 9 AM- 5 PM Eastern time (UTC/GMT- 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP