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Proteasome Inhibitor
Bortezomib + Rituximab for Waldenström's Macroglobulinemia
Phase 2
Waitlist Available
Led By Sheeba Thomas, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with symptomatic macroglobulinemic lymphoma who have had no prior treatment, or whose prior treatment has been limited to steroids and/or alpha-interferon, are eligible. Macroglobulinemic lymphoma includes patients with either biopsy proven clonal lymphocytic or lymphoplasmacytic proliferation and monoclonal IgM. Also included are symptomatic patients with clonal proliferation producing a pathologic monoclonal IgM that causes cryoglobulinemia, peripheral neuropathy or cold agglutinin hemolytic anemia.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 3 (35 day) cycles of treatment
Awards & highlights
Study Summary
This trial is testing if a combination of drugs can help to control WM, as well as the safety and tolerability of the combination.
Who is the study for?
This trial is for adults with Waldenstrom's Macroglobulinemia who haven't had prior treatment or only had steroids/alpha-interferon. They must have no serious heart issues, acceptable liver and kidney function, not be pregnant or breastfeeding, and willing to use birth control. People with certain health conditions like severe neuropathy, active hepatitis B, recent heart attack, other active cancers (except some skin cancers), or very low blood counts are excluded.Check my eligibility
What is being tested?
The study tests if a combination of drugs called Bortezomib and Rituximab can manage Waldenstrom's Macroglobulinemia effectively. It also evaluates the safety of this combo followed by other treatments and checks if it allows stem cell collection for potential future transplants.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs' components (like boron or murine proteins), nerve damage (neuropathy) if already present could worsen, fatigue from anemia due to bone marrow involvement in disease process might increase after therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptomatic macroglobulinemic lymphoma with limited or no prior treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 3 (35 day) cycles of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 3 (35 day) cycles of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participants Ability to Collect Stem Cells After Treatment With Bortezomib and Rituximab
Response Rate After 2 Cycles of Treatment With Bortezomib and Rituximab
Response Rate After 3 Cycles of Treatment With Bortezomib and Rituximab
Side effects data
From 2008 Phase 2 trial • 20 Patients • NCT00006184100%
Injection site reaction
40%
Fatigue (asthenia, lethargy, malaise)
30%
Pruritus
30%
Platelets
30%
Chest pain (non-cardiac and non-pleuritic)
30%
Bone pain
30%
Headache
30%
Myalgia (muscle ache)
30%
SGPT (ALT)
30%
Abdominal pain or cramping
20%
Alkaline phosphatase
20%
Hypokalemia
20%
Dizziness/lightheadedness
20%
Arthralgia (joint pain)
20%
Hypomagnesemia
20%
Pain - Other
20%
Rash/desquamation
20%
Rigors/chills
20%
SGOT (AST)
10%
Hypoalbuminemia
10%
Hypocalcemia
10%
Hot flashes/flushes
10%
Hypophosphatemia
10%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
10%
Lymphopenia
10%
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis
10%
Dry skin
10%
Constipation
10%
Hypotension
10%
Joint, muscle, or bone (osseous)- Other (Calf cramping)
10%
Hypercalcemia
10%
Skin-Other (Drug reaction face, hands, neck)
10%
Hematologic-Other (Splenomegaly in donor-resolved)
10%
Dyspnea (shortness of breath)
10%
Rash/desquamation for BMT
10%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donor - Vaccination Generation Group
Recipient - Chemotherapy Group
Trial Design
1Treatment groups
Experimental Treatment
Group I: Bortezomib + RituximabExperimental Treatment3 Interventions
Bortezomib 1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
2005
Completed Phase 2
~1140
Rituximab
1999
Completed Phase 4
~1880
Valacyclovir
2008
Completed Phase 4
~2520
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,735 Total Patients Enrolled
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,868 Total Patients Enrolled
Sheeba Thomas, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
61 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding, confirmed by a negative pregnancy test.My platelet count is low, but it's because of my lymphoma or enlarged spleen.I have moderate to severe nerve damage in my hands or feet.My white blood cell count is low, but it's because of my lymphoma.My kidney function is impaired due to my lymphoma.I have received more than 450 mg/m^2 of anthracyclines in my lifetime.I agree to use contraception throughout the study.I haven't had a heart attack in the last 6 months and don't have severe heart issues.I do not have an active cancer other than non-melanoma skin cancer or cervical carcinoma in situ.My liver and kidney functions are within the required levels, or my kidney issues are due to my lymphoma.I have symptomatic macroglobulinemic lymphoma with limited or no prior treatment.I am a woman who is post-menopausal, surgically sterilized, or will use birth control during the study.Your heart beats at a rate of 50 beats per minute or more.My daily activity is significantly limited due to my health.I have an active hepatitis B infection.You are allergic to boron, mannitol, or proteins from mice.
Research Study Groups:
This trial has the following groups:- Group 1: Bortezomib + Rituximab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for potential participants in this investigation?
"Data on clinicaltrials.gov indicates that this medical trial has reached its participant capacity and is not currently recruiting participants, despite being last updated nearly 3 months ago. However, 624 other trials are actively seeking patients at the moment."
Answered by AI
What safety protocols are in place for administering Bortezomib to patients?
"Bortezomib's safety has been studied at length, which earned it a rating of 2 on our team's scale. However, there is yet to be any clinical data confirming its efficacy in treatment."
Answered by AI
For which ailments is the drug Bortezomib typically employed?
"Bortezomib can be used to combat diffuse large b-cell lymphoma, genital herpes and human immunodeficiency virus type 1 infection."
Answered by AI
How many participants are eligible to join this clinical experiment?
"At present, this research project is not searching for any new participants. It was first listed on August 1st 2006 and last updated on April 29th 2022. For those looking to join a similar trial, there are 83 trials actively enrolling patients suffering from Waldenstrom Macroglobulinemia and 541 researching Bortezomib that have open enrollment slots available."
Answered by AI
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