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Bortezomib for Mantle Cell Lymphoma

Q: What further experiments involving bortezomib have been undertaken?

The initial clinical trial of bortezomib was conducted in 2004 at the NIH Clinical Center. Since then, a collective 383 studies have been finished with 142 more actively recruiting patients - many from Lake Success, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>.

Q: How many participants are being enrolled in this experiment?

This research initiative is no longer recruiting. This study was first published on June 1st 2006 and underwent its latest edit on August 16th 2021. To find other trials, there are 1719 <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>-mantle cell studies actively searching for patients and 142 bortezomib studies accepting volunteers at this time.

Q: Who is eligible for enrollment in this experiment?

This medical study is recruiting 151 individuals aged 18 to 69, who are diagnosed with mantle-cell <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>. To be considered for enrolment, participants must have stage I-IV of the disease and no active CNS involvement; furthermore, those possessing nodular histology should have Ann Arbor III/IV level while patients from other categories may join regardless of their stage. Patients previously treated by chemotherapy or rituximab can enroll as well though radiation therapy has been prohibited.

Q: Has bortezomib obtained clearance from the Food and Drug Administration?

The safety of bortezomib was evaluated and given a score 2 due to limited data on efficacy, but the available evidence suggests it is relatively safe.

Q: Are there any openings remaining in this research trial?

This clinical trial is not currently enrolling patients. It was initially posted on June 1st 2006 and last updated August 16th 2021. Alternatively, there are 1719 studies for individuals with <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> or mantle-cell actively seeking participants as well as 142 trials involving bortezomib that require subjects.

Q: Are individuals aged 50 and above being included in the ongoing trial?

To meet the qualifications of this trial, prospective participants must between 18 and 69 years old.

Q: Are there a substantial number of healthcare institutions conducting this research in North America?

Patients have the opportunity to enrol in this trial at Monter <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center of the North Shore-LIJ Health System located in Lake Success, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>, <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> Hematology Associates of Central <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>, PC - Peoria situated in Peoria and Long Island Jewish Medical Center positioned in New Hyde Park. An additional 48 sites are also available for patient enrollment.

Phase 2

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

D. ≥ 3 weeks since prior chemotherapy.

Age ≥ 18 years and < 70 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study Summary

This trial is studying how well bortezomib works after combination chemotherapy, rituximab, and an autologous stem cell transplant in treating mantle cell lymphoma.

Who is the study for?

This trial is for adults under 70 with newly diagnosed mantle cell lymphoma, who have not been treated or have had only one treatment cycle. They must not be pregnant, agree to birth control use, and cannot have active second cancers or HIV. Eligible patients should not have a history of severe reactions to mouse proteins and must meet specific health criteria including heart function and liver condition.Check my eligibility

What is being tested?

The study tests the effectiveness of bortezomib following combination chemotherapy, rituximab therapy, and an autologous stem cell transplant in treating mantle cell lymphoma. The goal is to see if this approach can better eliminate cancer cells or prevent the disease from returning.See study design

What are the potential side effects?

Bortezomib may cause side effects such as nerve damage leading to pain or numbness, digestive issues like nausea or diarrhea, low blood counts increasing infection risk, fatigue, and allergic reactions. Chemotherapy can also cause hair loss, mouth sores, and increased bleeding risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It has been over 3 weeks since my last chemotherapy session.

Select...

I am between 18 and 70 years old.

Select...

I have had no or just one round of chemotherapy or rituximab.

Select...

I do not take corticosteroids regularly for any condition.

Select...

I have not had radiation therapy for mantle cell lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival Rate at 18 Months

Secondary outcome measures

Bortezomib

Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.

Overall Survival

Side effects data

From 2012 Phase 3 trial • 11 Patients • NCT01078454

40%

Fatigue

40%

Nausea

40%

Generalized muscle weakness

20%

Dizziness

20%

Constipation

20%

Anorexia

20%

Diarrhea

20%

Lung infection

20%

Platelet count decreased

20%

Hypocalcemia

20%

Peripheral motor neuropathy

20%

Hyperglycemia

20%

Anemia

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (B-Mel-Dex)

Arm A (Mel-Dex)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B consolidation therapyExperimental Treatment1 Intervention

Patients receive bortezomib 1.3 mg/m^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.

Group II: Arm A maintenance therapyExperimental Treatment1 Intervention

Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

217,487 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,002 Total Patients Enrolled

Millennium Pharmaceuticals, Inc.Industry Sponsor

404 Previous Clinical Trials

46,763 Total Patients Enrolled

Media Library

bortezomib Clinical Trial Eligibility Overview. Trial Name: NCT00310037 — Phase 2

Mantle Cell Lymphoma Research Study Groups: Arm B consolidation therapy, Arm A maintenance therapy

Mantle Cell Lymphoma Clinical Trial 2023: bortezomib Highlights & Side Effects. Trial Name: NCT00310037 — Phase 2

bortezomib 2023 Treatment Timeline for Medical Study. Trial Name: NCT00310037 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What further experiments involving bortezomib have been undertaken?

"The initial clinical trial of bortezomib was conducted in 2004 at the NIH Clinical Center. Since then, a collective 383 studies have been finished with 142 more actively recruiting patients - many from Lake Success, New york."

Answered by AI

How many participants are being enrolled in this experiment?

"This research initiative is no longer recruiting. This study was first published on June 1st 2006 and underwent its latest edit on August 16th 2021. To find other trials, there are 1719 lymphoma-mantle cell studies actively searching for patients and 142 bortezomib studies accepting volunteers at this time."

Answered by AI

Who is eligible for enrollment in this experiment?

"This medical study is recruiting 151 individuals aged 18 to 69, who are diagnosed with mantle-cell lymphoma. To be considered for enrolment, participants must have stage I-IV of the disease and no active CNS involvement; furthermore, those possessing nodular histology should have Ann Arbor III/IV level while patients from other categories may join regardless of their stage. Patients previously treated by chemotherapy or rituximab can enroll as well though radiation therapy has been prohibited."

Answered by AI

Has bortezomib obtained clearance from the Food and Drug Administration?

"The safety of bortezomib was evaluated and given a score 2 due to limited data on efficacy, but the available evidence suggests it is relatively safe."

Answered by AI

Are there any openings remaining in this research trial?

"This clinical trial is not currently enrolling patients. It was initially posted on June 1st 2006 and last updated August 16th 2021. Alternatively, there are 1719 studies for individuals with lymphoma or mantle-cell actively seeking participants as well as 142 trials involving bortezomib that require subjects."

Answered by AI

Are individuals aged 50 and above being included in the ongoing trial?

"To meet the qualifications of this trial, prospective participants must between 18 and 69 years old."

Answered by AI

Are there a substantial number of healthcare institutions conducting this research in North America?

"Patients have the opportunity to enrol in this trial at Monter Cancer Center of the North Shore-LIJ Health System located in Lake Success, New york, Oncology Hematology Associates of Central Illinois, PC - Peoria situated in Peoria and Long Island Jewish Medical Center positioned in New Hyde Park. An additional 48 sites are also available for patient enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bortezomib After Combination Chemotherapy, Rituximab, and an Autologous Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma

2006. "Bortezomib After Combination Chemotherapy, Rituximab, and an Autologous Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00310037.

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