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Proteasome Inhibitor

Bortezomib for Multiple Myeloma ((Mel/MelVel) Trial)

Phase 3
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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 5 Other Conditions
Pivotal Trial

Summary

This trial will test if adding the immunotherapy drug Nivolumab to Melphalan will help patients with multiple myeloma.

Eligible Conditions
  • Multiple Myeloma
  • Stem Cell Transplant

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562
43%
Weight decreased
29%
Cough
29%
Thrombocytopenia
29%
Nausea
29%
Decreased appetite
21%
Anaemia
21%
Fatigue
21%
Constipation
21%
Diarrhoea
14%
Oedema peripheral
14%
Pneumonia
14%
Neuropathy peripheral
14%
Paraesthesia
14%
Cataract
14%
Vomiting
14%
Headache
7%
Fungal skin infection
7%
Urinary tract infection
7%
Asthma
7%
Disturbance in attention
7%
Respiratory syncytial virus infection
7%
Neutropenia
7%
Peripheral swelling
7%
Mental status changes
7%
Lower respiratory tract infection
7%
Hyperthyroidism
7%
Back pain
7%
Pain in extremity
7%
Hyponatraemia
7%
Skin lesion
7%
Oropharyngeal pain
7%
Pyrexia
7%
Cardiac failure
7%
Hepatitis
7%
Pharyngitis
7%
Pollakiuria
7%
Non-cardiac chest pain
7%
C-reactive protein increased
7%
Taste disorder
7%
Haemorrhagic transformation stroke
7%
Abdominal pain
7%
Insomnia
7%
Dyspepsia
7%
Haemoglobin decreased
7%
Infection
7%
Hyperglycaemia
7%
Toothache
7%
Ecchymosis
7%
Upper respiratory tract infection
7%
Nasopharyngitis
7%
Viral infection
7%
Hypertension
7%
Muscular weakness
7%
Bronchiectasis
7%
Basal cell carcinoma
7%
Hypophagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
SdX Arm: Selinexor + Dexamethasone
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
SVd Arm: Selinexor + Bortezomib + Dexamethasone
Vd Arm: Bortezomib + Dexamethasone

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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tandem Transplantation with Melphalan and BortezomibExperimental Treatment1 Intervention
Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib D-mannitol
FDA approved

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
135 Previous Clinical Trials
30,189 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,274 Patients Enrolled for Multiple Myeloma
Michele Donato, MDPrincipal InvestigatorJohn Theurer Cancer Center at Hackensack University Medical Center
5 Previous Clinical Trials
174 Total Patients Enrolled
2 Trials studying Multiple Myeloma
98 Patients Enrolled for Multiple Myeloma
~9 spots leftby Nov 2025
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