- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01453101
Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma (Flu-Mel-Vel)
A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib
Study Overview
Status
Conditions
Intervention / Treatment
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%.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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New Jersey
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Hackensack, New Jersey, United States, 07601
- John Theurer Cancer Center at Hackensack University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Fludarabine, Melphalan, Bortezomib
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: Subjects will be followed for progression-free survival for at least 36 months
|
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.
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Subjects will be followed for progression-free survival for at least 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: Up to 3 years
|
Overall survival (OS): Defined as time from the first dose of administration to death from any cause
|
Up to 3 years
|
Overall Response Rate
Time Frame: Up to 3 years
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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 |
Up to 3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Melphalan
- Bortezomib
- Fludarabine
- Fludarabine phosphate
Other Study ID Numbers
- PRO1261
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
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National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
-
Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on Fludarabine monophosphate, melphalan, Bortezomib
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Children's Hospital Los AngelesNational Cancer Institute (NCI)Completed
-
PNP Therapeutics, Inc.CompletedHead and Neck CancerUnited States
-
University of Illinois at ChicagoCompletedAcute Myeloid Leukemia | Polycythemia Vera | Multiple Myeloma | Myelofibrosis | Acute Leukemia | Chronic Myelogenous Leukemia | Aplastic Anemia | Myeloproliferative Disorder | Hodgkin's Disease | Malignant Lymphoma | Lymphocytic LeukemiaUnited States
-
Case Comprehensive Cancer CenterCompletedSickle Cell Disease | Sickle Cell Anemia | SCDUnited States
-
National Guard Health AffairsUnknown
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Uppsala UniversityDalarna County Council, Sweden; Uppsala County Council, SwedenNot yet recruitingMyeloma Multiple
-
University Hospital, ToulouseMinistry of Health, France; Janssen, LPCompletedMultiple MyelomaFrance, Belgium
-
Dartmouth-Hitchcock Medical CenterMillennium Pharmaceuticals, Inc.CompletedMyelodysplastic Syndromes | Acute Myelogenous LeukemiaUnited States
-
University of California, San FranciscoTerminatedMultiple Myeloma | Patient ParticipationUnited States
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University of California, San FranciscoWithdrawn