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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00718419
First received: July 16, 2008
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Waldenstrom's Macroglobulinemia
Multiple Myeloma
Drug: Enzastaurin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Multicenter Phase 2 Study of Single-Agent Enzastaurin HCl in Previously Treated Waldenstrom's Macroglobulinemia or Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Safety and Adverse Events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 46
Study Start Date: July 2008
Study Completion Date: August 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718419

Locations
United States, Massachusetts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Boston, Massachusetts, United States, 02115
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
La Roche Sur Yon, France, 85925
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nantes, France, 44093
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nimes, France, 30029
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00718419     History of Changes
Other Study ID Numbers: 11481, H6Q-MC-S042
Study First Received: July 16, 2008
Last Updated: September 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Waldenstrom's Macroglobulinemia
Multiple Myeloma

Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 14, 2014