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Proteasome Inhibitor
Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older
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
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 • NCT0311056250%
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
8%
Oedema peripheral
8%
Pneumonia
6%
Lymphopenia
6%
Dizziness
6%
Insomnia
6%
Dehydration
6%
Back pain
6%
Leukopenia
6%
Bronchitis
6%
Cough
5%
Acute kidney injury
5%
Abdominal pain
5%
Muscular weakness
5%
Lower respiratory tract infection
3%
Pain in extremity
3%
Sepsis
3%
Hyperglycaemia
3%
Urinary tract infection
3%
Nasopharyngitis
3%
Hyponatraemia
3%
Toothache
3%
Disturbance in attention
3%
Cardiac failure
3%
Hypertension
2%
Blood uric acid increased
2%
Cardiac failure acute
2%
Pulmonary contusion
2%
Peripheral swelling
2%
Blood creatinine increased
2%
Paraesthesia
2%
Infection
2%
Respiratory syncytial virus infection
2%
Dyspepsia
2%
Syncope
2%
Clostridium difficile infection
2%
Compression fracture
2%
Multiple fractures
2%
Myocardial infarction
2%
C-reactive protein increased
2%
Cerebral haemorrhage
2%
Ischaemic stroke
2%
Sudden death
2%
Oropharyngeal pain
2%
Cognitive disorder
2%
Confusional state
2%
Influenza
2%
Septic shock
2%
Osteonecrosis of jaw
2%
Taste disorder
2%
Hyperkalaemia
2%
Depression
2%
Cerebrovascular accident
2%
Bronchitis viral
2%
Embolism
2%
Haemoglobin decreased
100%
80%
60%
40%
20%
0%
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
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
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
135 Previous Clinical Trials
30,259 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,356 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