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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.

Must not have

Patient has >/= Grade 2 peripheral neuropathy on baseline evaluation.

Patient with a lifetime cumulative dose of > 450 mg/m^2 of anthracyclines.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 3 (35 day) cycles of treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have symptomatic macroglobulinemic lymphoma with limited or no prior treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe nerve damage in my hands or feet.

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I have received more than 450 mg/m^2 of anthracyclines in my lifetime.

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I haven't had a heart attack in the last 6 months and don't have severe heart issues.

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My daily activity is significantly limited due to my health.

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I have an active hepatitis B infection.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 3 (35 day) cycles of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

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 2022 Phase 3 trial • 402 Patients • NCT03110562

50%

Thrombocytopenia

45%

Anaemia

39%

Nausea

29%

Decreased appetite

29%

Diarrhoea

27%

Weight decreased

24%

Neuropathy peripheral

24%

Vomiting

23%

Fatigue

21%

Neutropenia

21%

Cataract

15%

Asthenia

12%

Upper respiratory tract infection

11%

Pyrexia

11%

Constipation

Oedema peripheral

Pneumonia

Lymphopenia

Dizziness

Insomnia

Dehydration

Back pain

Leukopenia

Bronchitis

Cough

Acute kidney injury

Abdominal pain

Muscular weakness

Lower respiratory tract infection

Pain in extremity

Sepsis

Hyperglycaemia

Urinary tract infection

Nasopharyngitis

Hyponatraemia

Toothache

Disturbance in attention

Cardiac failure

Hypertension

Embolism

Peripheral swelling

Haemoglobin decreased

Blood uric acid increased

Cardiac failure acute

Pulmonary contusion

Blood creatinine increased

Paraesthesia

Infection

Respiratory syncytial virus infection

Dyspepsia

Syncope

Clostridium difficile infection

Compression fracture

Multiple fractures

Myocardial infarction

C-reactive protein increased

Cerebral haemorrhage

Ischaemic stroke

Sudden death

Oropharyngeal pain

Cognitive disorder

Confusional state

Influenza

Septic shock

Osteonecrosis of jaw

Taste disorder

Hyperkalaemia

Depression

Cerebrovascular accident

Bronchitis viral

100%

80%

60%

40%

20%

Study treatment Arm

SVdX Arm: Selinexor + Bortezomib + Dexamethasone

SdX Arm: Selinexor + Dexamethasone

SVd Arm: Selinexor + Bortezomib + Dexamethasone

Vd Arm: Bortezomib + Dexamethasone

Awards & Highlights

No Placebo-Only Group

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

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 3

~1410

Rituximab

1999

Completed Phase 4

~2990