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Bortezomib for Mantle Cell Lymphoma

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

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 5 Other Conditions

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.

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.

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.

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I am between 18 and 70 years old.

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

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I do not take corticosteroids regularly for any condition.

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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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival Rate at 18 Months

Secondary study objectives

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)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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