Status:
COMPLETED
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial studies the side effects and best dose of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients with multiple myeloma tha...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) when administered with or without cyclophosphamide ...
Eligibility Criteria
Inclusion
- Myeloma relapsing from partial response or better
- Patients relapsing \> 18 months from transplant if not on maintenance, or
- If off maintenance, discontinued at least 6 months ago, or
- If relapsing on maintenance, at least 3 years from transplant, or
- Off prior myeloma therapy at least 6 months ago
- Sufficient tumor burden that is assessable for response
- Serum M-spike \>= 0.5 g/dL, or
- If immunoglobulin A (IgA) myeloma, IgA \> 1000 mg/dL, or
- Difference between involved and uninvolved free light chain (dFLC) \> 10 mg/dL, or
- Urine M-spike \>= 200 mg/24 hours, or
- Bone marrow plasmacytosis \>= 10%, or
- Plasmacytoma \>= 2 cm in diameter
- Absolute neutrophil count (ANC) \>= 1000/uL
- Platelets (PLT) \>= 50,000/uL
- Hemoglobin \>= 8.5 g/dl
- Aspartate aminotransferase (AST) =\< 2 times upper limit of normal
- Creatinine \< 2 times upper limit of normal
- Total bilirubin =\< 1.5 x upper limit of normal
- International normalized ratio (INR) =\< 1.4 x ULN at the time of registration
- Ability to provide informed consent
- Willingness to return to Mayo Clinic Rochester for follow-up
- Life expectancy \>= 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Willingness to provide all biological specimens as required by the protocol
- Negative serum pregnancy test done =\< 7 days prior to registration for women of childbearing potential only
- Measles antibody titer on the BioRad Multiplex assay less than or equal to 1.0
Exclusion
- Uncontrolled infection
- Active tuberculosis
- Any myeloma directed therapy within 12 weeks of registration including plasmapheresis or transfusion
- New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review
- Active central nervous system (CNS) disorder or seizure disorder
- Human immunodeficiency virus (HIV) positive test result
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration \[FDA\] approved indication and in the context of a research investigation)
- Previous exposure to heat inactivated measles virus vaccine (this vaccine was given to some individuals between the years of 1963-1967)
- Any of the following:
- Pregnant women or women of reproductive ability who are unwilling to use effective contraception
- Nursing women
- Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment
- Evidence of chronic or acute graft versus host disease or on-going treatment for graft versus host disease from prior allogeneic stem cell transplantation
- Exposure to household contacts =\< 15 months old or household contact with known immunodeficiency
Key Trial Info
Start Date :
November 30 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00450814
Start Date
November 30 2006
End Date
November 20 2019
Last Update
December 16 2019
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905