NCT00422799 · REGISTRY CONDITION SEARCH

Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2020-10-27

In this study, we are trying to find out if the combination of these two drugs is effective in treating Waldenstrom's macroglobulinemia (WM). The combination of these two drugs has not been studied for patients with relapsed or refractory macroglobulinemia. The U.S. Food and Drug Administration (FDA) has approved bortezomib for the treatment of multiple myeloma, a cancer that is closely related to Waldenstrom's macroglobulinemia.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia (WM)

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outcome · POSTED

Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Previously Untreated Waldenstrom's Macroglobulinemia (WM)

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outcome · POSTED

Time to Progression in Patients With WM

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outcome · POSTED

Duration of Response in Patients With WM

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * 18 years of age or older * Patients with previously untreated WM and those who have received prior therapy are eligible * Must have received prior therapy for their WM and have relapsed or refractory WM. * CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow cytometric analysis performed up to 3 months prior to enrollment. * Measurable disease * ECOG Performance Status 0,1, or 2 * Total bilirubin \< 2.0 mg/dl * AST \< 3 x ULN * Life expectancy of greater than 12 weeks Exclusion Criteria: * Uncontrolled infection * Other active malignancies * Cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks, prior to registration. * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational * Known to be HIV positive or HEP B positive * Radiation therapy less than 2 weeks prior to registration * Grade 2 or greater peripheral neuropathy * Myocardial infarction within 6 months rior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. * Hypersensitivity to bortezomib, boron, or mannitol * Pregnant or breast feeding women * Other investigational drugs within 14 days of enrollment * Serious medical or psychiatric illness likely to interfere with participation
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
bortezomib and rituximab
intervention Names
Drug: Bortezomib
Drug: Rituximab
label
bortezomib and rituximab
type
EXPERIMENTAL

interventions

arm Group Labels
bortezomib and rituximab
description
Once weekly for 3 weeks
name
Bortezomib
other Names
Velcade
type
DRUG
arm Group Labels
bortezomib and rituximab
description
Intravenously once a week for the first and fourth weeks of a cycle
name
Rituximab
other Names
Rituxan
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 63
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Overall Response Rate= Minor response (\>25%-50% reduction in monoclonal IgM from baseline + Partial Response (\>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)
measure
Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia (WM)
time Frame
2 Years
description
Overall Response Rate= Minor response (\>25%-50% reduction in monoclonal IgM from baseline + Partial Response (\>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)
measure
Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Previously Untreated Waldenstrom's Macroglobulinemia (WM)
time Frame
2 years

secondary Outcomes

description
Time to progresion is the defined as the time from study entry to disease progression (PD) or death. Patients without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum monoclonal IgM electrophoresis confirmed by a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease or symptoms attributable to WM.
measure
Time to Progression in Patients With WM
time Frame
5 Years
description
Time from documentation of first response to progressive disease.
measure
Duration of Response in Patients With WM
time Frame
5 Years

Full study description

brief Summary: In this study, we are trying to find out if the combination of these two drugs is effective in treating Waldenstrom's macroglobulinemia (WM). The combination of these two drugs has not been studied for patients with relapsed or refractory macroglobulinemia. The U.S. Food and Drug Administration (FDA) has approved bortezomib for the treatment of multiple myeloma, a cancer that is closely related to Waldenstrom's macroglobulinemia.
detailed Description: * Participants will receive 6 cycles of the study treatment with bortezomib and rituximab. Each cycle is 28 days long (4 weeks). * Participants will receive Rituximab intravenously once a week for the first and fourth cycles only. Participants will receive bortezomib once a week for three weeks on and one week off every cycle, for a total of 6 cycles. * During the rituximab infusion, the participants blood pressure and pulse will be monitored frequently. The rate of infusion may be decreased depending upon the side effects that are experienced. * Blood samples will be collected before the first dose and on follow up with every cycle. Blood counts will also be performed every week. * Routine physical exams will be performed at each evaluation. A PET/CAT scan of the chest, abdomen and pelvis at the end of treatment. This scan is required to assess the response of the participants disease. * In order to learn more on how bortezomib and rituximab affect WM, a bone marrow biopsy will be performed. * We anticipate that participants will complete the active therapy over a period of 6 cycles provided that they are benefiting from therapy and have not had any serious side effects. The participant will be followed every three months for 2 years for office visits and laboratory tests.

Source references

references

citation
Ghobrial IM, Hong F, Padmanabhan S, Badros A, Rourke M, Leduc R, Chuma S, Kunsman J, Warren D, Harris B, Sam A, Anderson KC, Richardson PG, Treon SP, Weller E, Matous J. Phase II trial of weekly bortezomib in combination with rituximab in relapsed or relapsed and refractory Waldenstrom macroglobulinemia. J Clin Oncol. 2010 Mar 10;28(8):1422-8. doi: 10.1200/JCO.2009.25.3237. Epub 2010 Feb 8.
pmid
20142586
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice