Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to find out if the combination of bortezomib (Velcade), dexamethasone (Decadron) and rituximab (Rituxan) is effective in treating Waldenstrom's macroglobulinemia.


Clinical Trial Description

- This is an open-label study which means both the patient and the doctor will know what drugs and doses the patient is receiving throughout the study.

- Patients will receive 8 cycles of study treatment with bortezomib, dexamethasone and rituximab. Each cycle is 21 days long. Therapy is given on the first, fourth, eighth and eleventh day of each cycle, followed by a 10 day rest period. The first 4 cycles will be given one after the other. Three months after completing the fourth cycle of therapy, patients will receive one cycle of therapy every three months for a total of four more cycles.

- On the first, fourth, eighth and eleventh day of each cycle, the patient will receive bortezomib and dexamethasone as an intravenous injection through a needle in your vein. On the eleventh day only, the patient will also receive rituximab as an intravenous infusion after getting bortezomib and dexamethasone.

- Prior to each infusion of rituximab therapy, the patient will be asked to take some medications to prevent or reduce side effects of rituximab. These medications are benadryl, tylenol, and possibly more steroids. The doctor will determine which of these drugs are appropriate for the individual patient.

- During the rituximab infusion, the patients blood pressure and pulse will be monitored frequently and the infusion rate may be decreased depending upon the side effects experienced.

- After therapy is completed, the patient will be followed every three months for 2 more years for office visits and laboratory tests to determine how well they are doing and if the therapy continues to benefit them. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00250926
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date October 2005
Completion date February 2009

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 NCT00150462 - Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies Phase 1
Completed NCT00165295 - Sildenafil Citrate in Waldenstrom's Macroglobulinemia Phase 2
Terminated NCT00142168 - CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia Phase 2
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
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