Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the number of patients with Waldenstrom's macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab, what the side effects are and how long the benefit will last.


Clinical Trial Description

- The study drug CC-5103 (lenalidomide) will be administered orally once daily for 21 days followed by 7 days of no CC-5103 (lenalidomide) (this will be one 28 day treatment cycle). This cycle will repeat itself every 28 days as long as the patient is tolerating the medication and there is no disease progression.

- Starting on the second week, patients will begin treatment with rituximab intravenously once a week for 4 weeks (week 2-5). Prior to each treatment, patients will receive medications to prevent or reduce the side effects of rituximab (benadryl, tylenol and possible decadron). During the infusion, the patients' blood pressure and pulse will be monitored frequently and the rate of infusion may decrease depending upon the side effects. Blood work will also be performed each week.

- On week 12 the disease status will be evaluated. A physical exam, blood test, CT scan and bone marrow biopsy may be repeated if necessary to fully evaluate the disease. If the disease has gone away completely, some tests may be repeated again to confirm this.

- If the disease has gotten worse after 12 weeks, then the patient will be removed from the study.

- If the disease is stable or getting better, the patient will continue with therapy. During weeks 13-16 rituximab infusions will be repeated and CC-5103 will continue to be taken daily for 21 days followed by 7 days of rest. This 28 day cycle may be repeated until the patient has completed 48 weeks (12 months) of treatment as long as the side effects are acceptable and the disease does not progress.

- All patients will undergo an off-study evaluation that includes a physical exam, blood work, CT scans and bone marrow biopsy. If the patient completes 78 weeks of therapy and the disease does not get worse, they will be evaluated every 12 weeks to determine the status of their disease for up to 2 years. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00142168
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Terminated
Phase Phase 2
Start date September 2004
Completion date April 2008

See also
  Status Clinical Trial Phase
Completed NCT02566265 - Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients Phase 2
Completed NCT00422656 - Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia Phase 2
Completed NCT00165295 - Sildenafil Citrate in Waldenstrom's Macroglobulinemia Phase 2
Completed NCT00150462 - Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies Phase 1
Suspended NCT02439138 - Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Phase 2
Completed NCT01470196 - Carfilzomib, Rituximab and Dexamethasone in Waldenstrom's Macroglobulinemia Phase 2
Completed NCT00250926 - Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia Phase 2
Terminated NCT03225716 - A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia Phase 1
Terminated NCT01744912 - Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies Phase 1
Completed NCT02363439 - Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401 Phase 1/Phase 2
Completed NCT00976248 - Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia Phase 2
Terminated NCT00575965 - Simvastatin in Waldenstrom's Macroglobulinemia Phase 2
Completed NCT00919139 - S0309, Repository: Blood/Bone Marrow From Pts. With Myeloma, WM, Amyloidosis, or MGUS. N/A
Completed NCT01614821 - Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia Phase 2
Active, not recruiting NCT01078974 - Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia Phase 1
Completed NCT00481871 - Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies Phase 1/Phase 2
Completed NCT00142116 - Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia Phase 2
Completed NCT02092909 - Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia Phase 1/Phase 2
Completed NCT00807677 - A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies Phase 1
Completed NCT01046006 - Bortezomib, Dexamethasone, and Rituximab in Previously Untreated Patients With Waldenstrom's Macroglobulinemia Phase 2