Multiple MyelomaPhase 2Flu-Mel-VelNCT01453101
Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma
A Phase 2 study testing Fludarabine monophosphate, melphalan, Bortezomib in people with Multiple Myeloma, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
The hypothesis for this study is that the regimen consisting of fludarabine, melphalan and bortezomib improves the progression free survival and the response rate compared to historical controls of fludarabine and melphalan alone. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Fludarabine monophosphate, melphalan, Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2010to 11 Jun 2020
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of multiple myeloma
- Have a suitable related or unrelated donor
- Age ≥18 but <70 yrs
- KPS of ≥70%
- Recovery from complications of previous therapies
Who cannot join
- Diagnosis other than multiple myeloma
- Chemotherapy or radiotherapy within 21 days of initiating treatment in this study
- Prior dose-intense therapy requiring HSC support within 56 days of initiating treatment in this study
- Uncontrolled bacterial, viral, fungal or parasitic infections
- Uncontrolled CNS metastases
- Known amyloid deposition in heart
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- Organ dysfunction
- LVEF <40% or cardiac failure not responsive to therapy
- FVC, FEV1, or DLCO <50% of predicted and/or receiving supplementary continuous oxygen
- Evidence of hepatic synthetic dysfunction, or total bilirubin >2x or AST >3x ULN
- Measured creatinine clearance <20 ml/min
- Sensory peripheral neuropathy grade 4 within 14 days of enrollment
- Karnofsky score <70% unless a result of bone disease directly caused by myeloma
- Life expectancy limited by another co-morbid illness
- Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
- Female subject is pregnant or breast-feeding (women) or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Documented hypersensitivity to fludarabine or melphalan or to bortezomib, boron or mannitol or any components of the formulation
- Patients unable or unwilling to provide consent
- Patient has a sustained platelet count of <30 x 10 9/L within 14 days before enrollment
- Patient has a sustained absolute neutrophil count of <1.0 x10 9/L within 14 days before enrollment
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant
- Patient has received other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib
The hypothesis for this study is that the regimen consisting of fludarabine, melphalan and bortezomib improves the progression free survival and the response rate compared to historical controls of fludarabine and melphalan alone.
Read the detailed description
Multiple myeloma is the second most prevalent blood cancer (10%) after non-hodgkin's lymphoma. It represents approximately 1% of all cancers and 2% of all cancer deaths. Although the peak age of onset of multiple myeloma is 70 years of age, recent statistics indicate both increasing incidence and earlier age of onset.
The historical control 2-year progression-free survival (PFS) is assumed to be 35%. The proposed therapy of fludarabine, melphalan and bortezomib is expected to improve the PFS by 20%.
- Conditions
- Multiple Myeloma
- Being tested
- Fludarabine monophosphate, melphalan, Bortezomib
- Keywords
- Multiple Myeloma, Transplant
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludarabine monophosphate, melphalan, BortezomibDrug
Also called Fludara, Phenylalanine Mustard, Velcade
- Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5.
- Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2
- Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan.
| Study group | Role | What they receive |
|---|---|---|
| Fludarabine, Melphalan, Bortezomib | Other | Not described Receives: Drug: Fludarabine monophosphate, melphalan, Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The main primary endpoint of this study is two-year progression free survival. Patients are considered a failure with respect to PFS if they die or experience disease progression or relapse. The time to this event is the time from transplantation to relapse/progression, initiation of non-protocol anti-myeloma therapy, or death from any cause. Subjects alive without confirmed disease progression will be censored at the time of last disease evaluation. Deaths without progression are treated as failures no matter when they occur.
Measured: Subjects will be followed for progression-free survival for at least 36 months
Secondary outcomes (2)
Overall Survival (OS)
Overall survival (OS): Defined as time from the first dose of administration to death from any cause
Measured: Up to 3 years
Overall Response Rate
Overall response rate: Defined as the composite endpoint of response to treatment which includes Complete Response (CR), Partial Response (PR), stable disease (SD) as defined in International Response Criteria.
International Myeloma Working Group Response Criteria for Multiple Myeloma:
CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study start9 Jun 2010
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453101
- Sponsor's protocol ID
- Pro00001261
- Acronym
- Flu-Mel-Vel
- Status last verified
- Mar 2026
- First submitted
- 13 Oct 2011
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes