Vaccine Therapy with or without Cyclophosphamide in Treating Patients with Recurrent or Refractory Multiple Myeloma
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: I/II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 06-005263
NCT ID: NCT00450814
Sponsor Protocol Number: MC038C
About this study
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 that has come back or does not respond to treatment. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vaccine therapy together with cyclophosphamide may be a safe treatment for multiple myeloma.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Age ≥ 18 years.
- Myeloma relapsed from complete response (CR) or very good partial response (VGPR)
- Sufficient tumor burden that is assessable for response
- Serum M-spike ≥ 0.5 g/dL, or
- If IgA myeloma, IgA > 1000 mg/dL, or
- difference in involved and uninvolved serum immunoglobulin free light chain >10 mg/dL, or
- Urine M-spike ≥200 mg/24 hours, or
- Bone marrow plasmacytosis ≥ 10%, or
- Extramedullary plasmacytoma ≥ 2 cm in diameter
- No prior myeloma directed therapy (other than bisphosphonate) past 12 weeks
- The following laboratory values obtained ≤ 14 days prior to study registration
- Absolute neutrophil count (ANC) ≥ 1000/μL
- Platelets (PLT) ≥ 50,000/μL
- 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 0.3 and absence of measles neutralizing antibody by plaque reduction neutralization assay
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Angela Dispenzieri, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office