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

NCT00718419 | Completed Phase 2 Results

• 2 other identifiers: 11481H6Q-MC-S042
• Study Type: interventional
• Target: 56
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Waldenstrom's Macroglobulinemia; Multiple Myeloma

Keywords

Waldenstrom's Macroglobulinemia; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Response (CR), Partial Response (PR) and Minimal Response (MR) or Minor Response (MinR): (Response Rate)

  European Group for Blood and Bone Marrow Transplant (EBMT) Response Criteria (RC) used for MM. CR: no serum/urine M protein for 6 weeks (wk), \<5% plasma cells in bone marrow (PCBM), no lytic bone lesions (LBL) size/number increase, no soft tissue plasmacytomas (STPC); PR: met some CR criteria plus maintain for 6 wk ≥50% serum monoclonal paraprotein (SPEP) and PCBM decrease, either decrease of ≥90% or \<200 mg light chain excretion (LCE), ≥50% STPC size decrease; MR: met some PR criteria plus maintain for 6 wk, a decrease of: 25-49% SPEP, 50-89% 24 hour urinary LCE, 25-49% PCBM, 25-49% STPC size. International Workshop on WM (IWWM) RC used for WM. CR: no serum M protein, malignant cells in BM, or lymphadenopathy/organomegaly; PR: ≥50% immunoglobulin M (IgM) and adenopathy/organomegaly (A/O) decrease; no new symptoms of WM. MinR: ≥25% to \<50% IgM decrease, no A/O progression; no cytopenias or clinical symptoms of WM.

  Baseline to measured progressive disease up to 40.51 months

Secondary Outcomes (3)

• Duration of Response (DOR)

  Time of response to time of measured progressive disease up to 38.37 months

• Time to Progressive Disease

  Baseline to measured progressive disease up to 40.51 months

• Number of Participants With Adverse Events (Safety and Adverse Events)

  Treatment start to 30 days after discontinuation of study treatment up to 23.40 months

Other Outcomes (1)

• Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment

  Study treatment discontinuation up to 30 days post study treatment discontinuation

Study Arms (1)

A: Enzastaurin

EXPERIMENTAL

Drug: Enzastaurin

Interventions

Enzastaurin DRUG

Enzastaurin: Cycle 1 Day 1 only: 3, 125-milligrams (mg) tablets three times on Day 1 (Day 1 total dose = 1125 mg) Day 2 onwards and subsequent Cycles: 2, 125-mg tablets orally twice a day (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.

Also known as: LY317615

A: Enzastaurin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Patients must have Waldenstrom's Macroglobulinemia (WM) or Multiple Myeloma (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 gram per deciliter (g/dL) or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200 milligrams (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 (ULN), have detectable lymphoplasmacytic (LPL) cells in the bone marrow, and be symptomatic for WM.
• Eastern Cooperative Oncology Group (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/microliter
• Platelet (PLT) count greater than or equal to 75,000/microliter
• Total bilirubin less than or equal to 1.5 x 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.

You may not qualify if:

• Prior allogeneic hematopoietic stem cell transplant.
• Are unable to discontinue use of non-Enzyme-Inducing Anti-Epileptic Drugs (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 2 mg daily) Coumadin for deep venous thrombosis (DVT) is allowed. In such cases, prothrombin time/ international normalized ratio (PT/INR) should be closely monitored.
• Have electrocardiogram (ECG) abnormalities including baseline 12-lead ECG with QTc interval of greater than 450 milliseconds (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 Carmustine (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 human immunodeficiency virus (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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

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, 02115, United States

Location

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, 85925, France

Location

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, 44093, France

Location

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.

Nîmes, 30029, France

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia; Multiple Myeloma

Interventions

enzastaurin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: August 1, 2012
• Last Updated: September 3, 2020
• Results First Posted: September 3, 2020

Record last verified: 2020-09

Locations

US (1); FR (3)