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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
Recovery from complications of prior therapy
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

Study Summary

This trial is testing a new combination of drugs to treat myeloma, compared to the current standard of care.

Eligible Conditions
  • Multiple Myeloma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You need to have recovered from any complications caused by previous treatments.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival Rate
Secondary outcome measures
Overall Survival Rate

Side effects data

From 2008 Phase 2 trial • 20 Patients • NCT00006184
100%
Injection site reaction
40%
Fatigue (asthenia, lethargy, malaise)
30%
Chest pain (non-cardiac and non-pleuritic)
30%
Bone pain
30%
Headache
30%
Myalgia (muscle ache)
30%
Platelets
30%
SGPT (ALT)
30%
Abdominal pain or cramping
30%
Pruritus
20%
Dizziness/lightheadedness
20%
Arthralgia (joint pain)
20%
Hypokalemia
20%
Hypomagnesemia
20%
Pain - Other
20%
Rash/desquamation
20%
Rigors/chills
20%
SGOT (AST)
20%
Alkaline phosphatase
10%
Hot flashes/flushes
10%
Hypocalcemia
10%
Constipation
10%
Dyspnea (shortness of breath)
10%
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis
10%
Hypoalbuminemia
10%
Hypotension
10%
Joint, muscle, or bone (osseous)- Other (Calf cramping)
10%
Rash/desquamation for BMT
10%
Skin-Other (Drug reaction face, hands, neck)
10%
Dry skin
10%
Hematologic-Other (Splenomegaly in donor-resolved)
10%
Hypercalcemia
10%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
10%
Hypophosphatemia
10%
Lymphopenia
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

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 2
~1140

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,181 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,357 Patients Enrolled for Multiple Myeloma
Michele Donato, MDPrincipal InvestigatorJohn Theurer Cancer Center at Hackensack University Medical Center
5 Previous Clinical Trials
257 Total Patients Enrolled
2 Trials studying Multiple Myeloma
181 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

Are there any other published papers that explore Bortezomib's effects?

"587 clinical trials have completed investigating bortezomib since 1997, when City of Hope Comprehensive Cancer Center first studied the medication. As of now, there are 249 ongoing trials, many based in Hackensack, New jersey."

Answered by AI

Are there any available positions for volunteers in this research project?

"This trial is no longer active. It was originally posted on 6/24/2010 and had its last update on 5/6/2022. However, there are 827 other clinical trials involving multiple myeloma that are currently recruiting patients and 249 Bortezomib trials with open enrollment.."

Answered by AI

How many people have been recruited for this clinical trial?

"This study is no longer recruiting new patients. It was initially posted on 6/24/2010 and updated for the last time on 5/6/2022. There are 827 other trials currently looking for participants with multiple myeloma and 249 studies involving Bortezomib that are still open to enrolling patients."

Answered by AI

What are some conditions that Bortezomib can help ameliorate?

"Bortezomib is not only useful in treating mantle cell lymphoma, but also stem cell transplant, amyloidosis, and multiple myeloma."

Answered by AI

What are the deleterious effects of Bortezomib on patients?

"Bortezomib's safety is estimated to be a 2 because, while there is data supporting its safety, no studies have been done yet to test its efficacy."

Answered by AI
Recent research and studies
~4 spots leftby Mar 2025