NCT00422799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2015

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

January 26, 2018

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

9.1 years

First QC Date

January 12, 2007

Results QC Date

December 27, 2017

Last Update Submit

October 6, 2020

Conditions

Waldenstrom's Macroglobulinemia

Keywords

relapsed Waldenstrom's macroglobulinemiarefractory Waldenstrom's macroglobulinemiaVelcadeWM

Outcome Measures

Primary Outcomes (2)

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

    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.)

    2 Years

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

    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.)

    2 years

Secondary Outcomes (2)

  • Time to Progression in Patients With WM

    5 Years

  • Duration of Response in Patients With WM

    5 Years

Study Arms (1)

bortezomib and rituximab

EXPERIMENTAL

bortezomib and rituximab

Drug: BortezomibDrug: Rituximab

Interventions

BortezomibDRUG

Once weekly for 3 weeks

Also known as: Velcade
bortezomib and rituximab
RituximabDRUG

Intravenously once a week for the first and fourth weeks of a cycle

Also known as: Rituxan
bortezomib and rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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: 20142586RESULT

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

BortezomibRituximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Irene M. Ghobrial
Organization
Dana-Farber Cancer Institute
Irene_Ghobrial@DFCI.HARVARD.EDU
(617) 632-4218

Study Officials

  • Irene Ghobrial, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2007

First Posted

January 17, 2007

Study Start

August 30, 2006

Primary Completion

October 9, 2015

Study Completion

October 9, 2015

Last Updated

October 27, 2020

Results First Posted

January 26, 2018

Record last verified: 2020-10

Locations

US(1)