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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
Age: 18-75 years at time of transplantation
Recovery from complications of prior therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
(Mel/MelVel) 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
(Mel/MelVel) Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria below(Mel/MelVel) Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the progression-free survival of patients with multiple myeloma treated with tandem cycles of high-dose melphalan followed by high-dose melphalan in combination with bortezomib with autologous HSC transplantation.
Secondary outcome measures
To determine the response rate, overall survival, and regimen-related toxicities of patients with multiple myeloma treated with high-dose melphalan or high-dose melphalan in combination with bortezomib given in tandem transplants.
Side effects data
From 2008 Phase 2 trial • 20 Patients • NCT00006184100%
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
(Mel/MelVel) 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
131 Previous Clinical Trials
28,098 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
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