NCT00250926 · REGISTRY CONDITION SEARCH

Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia

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: 2016-04-08

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.

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

Number of Participants With Adverse Events

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outcome · POSTED

Response Rate

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outcome · POSTED

Time to Best Response

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outcome · POSTED

Time to Progression

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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: * Clinicopathological diagnosis of Waldenstrom's macroglobulinemia (WM) * No previous therapy for WM * Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of greater than or equal to 2 times the upper limit of each institution's normal value * CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow cytometric analysis performed up to 3 months prior to enrollment * Karnofsky performance status \> 60 * Life expectancy \> 3 months * AST (SGOT) \< 3 x ULN * ALT (SGPT) \< 3 x ULN * Total bilirubin \< 2 x ULN * Calculated or measured creatinine clearance \> 30mL/minute * Serum sodium \> 130 mmol/L * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control * Male subject agrees to use an acceptable method for contraception for the duration of the study Exclusion Criteria: * Previous therapy for Waldenstrom's macroglobulinemia * Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association 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 dexamethasone, boron or mannitol * Pregnant or breast-feeding women * Serious medical or psychiatric illness likely to interfere with participation in this clinical study
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
intervention Names
Drug: Bortezomib
Drug: Dexamethasone
Drug: Rituximab
label
Bortezomib, Dexamethasone, Rituximab
type
EXPERIMENTAL

interventions

arm Group Labels
Bortezomib, Dexamethasone, Rituximab
description
Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles
name
Bortezomib
other Names
Bortezomib (Velcade)
type
DRUG
arm Group Labels
Bortezomib, Dexamethasone, Rituximab
description
Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles
name
Dexamethasone
other Names
Dexamethasone (Decadron)
type
DRUG
arm Group Labels
Bortezomib, Dexamethasone, Rituximab
description
Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles
name
Rituximab
other Names
Rituximab (Rituxan)
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 23
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
This outcome measure was to assess the safety and tolerability of bortezomib, dexamethasone and rituximab in patients with untreated Waldenstroms macroglobulinemia.
measure
Number of Participants With Adverse Events
time Frame
33.2 months
description
This outcome measure was to determine the response rate along with attainment of stable disease and time to disease progression following treatment with this patient population. The response rates were defined as follows. A complete response (CR) was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, absence of bone marrow disease by bone marrow biopsy and aspiration, and resolution of any adenopathy or splenomegaly. A near complete response (nCR) was defined as fulfilling all CR criteria in the presence of a positive immunofixation study. Patients with very good partial response (VGPR), partial response (PR), and minor response (MR) were defined as having a ≥ 90%, ≥ 50%, and 25% to 49% reduction in serum IgM levels, respectively. Progressive disease (PD) occurred when a more than 25% increase in serum IgM level or progression of clinically significant disease parameters was observed.
measure
Response Rate
time Frame
33.2 months
measure
Time to Best Response
time Frame
33.2 months
description
Progressive Disease (PD) will be defined as a greater than 25% increase in serum IgM monoclonal protein levels from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s).
measure
Time to Progression
time Frame
42 months

Full study description

brief 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.
detailed 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.

Source references

references

citation
Treon SP, Ioakimidis L, Soumerai JD, Patterson CJ, Sheehy P, Nelson M, Willen M, Matous J, Mattern J 2nd, Diener JG, Keogh GP, Myers TJ, Boral A, Birner A, Esseltine DL, Ghobrial IM. Primary therapy of Waldenstrom macroglobulinemia with bortezomib, dexamethasone, and rituximab: WMCTG clinical trial 05-180. J Clin Oncol. 2009 Aug 10;27(23):3830-5. doi: 10.1200/JCO.2008.20.4677. Epub 2009 Jun 8.
pmid
19506160
type
RESULT

Source notices and limitations

Discovery and provenance

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source url
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Preserved source evidence · Not medical advice