Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma

In brief

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 (recurrent) or has not responded to previous treatment (refractory). 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 better treatment for multiple myeloma.

Key facts

Study ID

NCT00450814

Run by

Mayo Clinic

People needed

48

Starts

2006-11-30

Expected to finish

2019-11-20

Last updated by the study team

2019-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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