Waldenstrom's Macroglobulinemia Clinical Trial
Official title:
A Phase II Study of the Combination Bortezomib (Velcade, PS-341), Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia
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.
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |