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Proteasome Inhibitor

Bortezomib for Multiple Myeloma

Phase 2

Waitlist Available

Led By Michele Donato, MD

Research Sponsored by Hackensack Meridian Health

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be followed post transplant for a minimum of 3 years, and after that may be monitored as part of the study indefinitely

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two treatments for patients undergoing stem cell transplants. One treatment uses melphalan alone, while the other combines melphalan with bortezomib. Melphalan damages cancer cell DNA, and bortezomib disrupts protein breakdown in cancer cells, aiming to improve treatment outcomes. Bortezomib and melphalan have been used together in various studies to treat multiple myeloma, showing improved results.

Eligible Conditions

Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be followed post transplant for a minimum of 3 years, and after that may be monitored as part of the study indefinitely

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be followed post transplant for a minimum of 3 years, and after that may be monitored as part of the study indefinitely

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed post transplant for a minimum of 3 years, and after that may be monitored as part of the study indefinitely 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

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562

43%

Weight decreased

29%

Decreased appetite

29%

Cough

29%

Thrombocytopenia

29%

Nausea

21%

Fatigue

21%

Anaemia

21%

Constipation

21%

Diarrhoea

14%

Neuropathy peripheral

14%

Oedema peripheral

14%

Pneumonia

14%

Paraesthesia

14%

Cataract

14%

Vomiting

14%

Headache

Urinary tract infection

Bronchiectasis

Asthma

Disturbance in attention

Respiratory syncytial virus infection

Neutropenia

Peripheral swelling

Mental status changes

Lower respiratory tract infection

Hyperthyroidism

Back pain

Pain in extremity

Basal cell carcinoma

Hyponatraemia

Skin lesion

Oropharyngeal pain

Pyrexia

Cardiac failure

Hepatitis

Pharyngitis

Hypophagia

Pollakiuria

Non-cardiac chest pain

C-reactive protein increased

Taste disorder

Haemorrhagic transformation stroke

Abdominal pain

Insomnia

Dyspepsia

Haemoglobin decreased

Infection

Hyperglycaemia

Toothache

Ecchymosis

Upper respiratory tract infection

Nasopharyngitis

Fungal skin infection

Viral infection

Hypertension

Muscular weakness

100%

80%

60%

40%

20%

Study treatment Arm

SdX Arm: Selinexor + Dexamethasone

SVdX Arm: Selinexor + Bortezomib + 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

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Arm BExperimental Treatment1 Intervention

Bortezomib: Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.

Group II: Treatment AActive Control1 Intervention

Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour. Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1. Dosing will be based on body surface area calculated using actual body weight Stem cell infusion: Stem cell infusion will occur on day 0 and will be at least 20 hours after the infusion of melphalan. The infusion of peripheral blood stem cells will be done in accordance with the Blood and Marrow Transplant program standard operating procedures. Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day starting on day+3 then daily starting on day 9 until engraftment (at least).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 3

~1410

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