PATIENT INFORMATION
Phase I Trial of Systemic Administration of Edmonston Strain of Measles Virus, Genetically
Engineered to Express NIS, with or without Cyclophosphamide, in Patients with Recurrent or
Refractory Multiple Myeloma
Background:
Many cancers, including multiple myeloma, overexpress a specific protein, CD46, which allows
them to evade destruction by the immune system. Laboratory strains of measles virus seek out
this protein and use it as a receptor by which to enter the cancer cells. Upon entry, the virus
spreads, infecting nearby tumor cells and fusing them together, increasing cancer cell death (cells
with multiple nuclei cannot survive).
This study uses a strain of measles virus which was engineered to carry an additional gene that
codes for the sodium iodide symporter (NIS) protein. NIS is normally produced by the thyroid
where it attracts and concentrates iodine. This characteristic of the NIS protein can be exploited
as a target in cancer therapy because it can concentrate radioactive iodine, thus providing a way
to selectively irradiate cancer cells, image the tumors and monitor regression.
Sponsors: National Cancer Institute and the Harold W. Siebens Foundation
Purpose of Study:
To determine the safety and toxicity of the intravenous administration of an Edmonston vaccine
strain measles virus engineered to express the thyroidal sodium iodide symporter (MV-NIS) when
administered with or without cyclophosphamide in patients with relapsed or refractory multiple
myeloma.
Phase I
Inclusion criteria
Age 18 years.
· Relapsed or refractory myeloma previously treated with 2 or more non-overlapping
chemotherapeutic combinations
· The following laboratory values obtained 14 days prior to study registration
o
ANC 1000/L
o
PLT 100,000/L
o
Hemoglobin 8.5 g/dl
o
AST 2 times upper limit of normal
o
Creatinine < 2 times upper limit of normal
o
Total bilirubin 1.5 x upper limit of normal
o
INR 1.4 x ULN at the time of registration
o
TSH (0.3-5.0) and free thyroxine (0.8-1.87)
· Ability to provide informed consent.
· Willingness to return to Mayo Clinic Rochester for follow-up.
· Life expectancy 12 weeks.
· ECOG performance status (PS) 0, 1 or 2.
· Willingness to provide all biological specimens as required by the protocol
· Negative serum pregnancy test.

---

Exclusion criteria
· Availability of known standard therapy that is definitely capable of extending life expectancy.
· Uncontrolled infection.
·
Active tuberculosis.
· Any of the following prior therapies:
o
Chemotherapy 3 weeks prior to study registration
o
Immunotherapy 4 weeks prior to study registration
o
Biologic therapy 4 weeks prior to study registration
· New York Heart Association classification III or IV, known symptomatic coronary artery
disease, or symptoms of coronory artery disease on systems review, or known cardiac
arrhythmias (atrial fibrillation or SVT).
· Active CNS disorder or seizure disorder.
· HIV positive test result.
· Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
considered investigational (used for a non-FDA approved indication and in the context of a
research investigation).
· Allergy to iodine. This does not include reactions to intravenous contrast materials.
· 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:
o
Pregnant or Nursing women
o
Men or women who are unwilling to use contraception.
· Prior allogeneic hematopoietic stem cell transplantation.
· Exposure to household contacts 15 months old or household contact with known
immunodeficiency.
Site Information:
Angela Dispenzieri, M.D.
Mayo Clinic
200 First Street SW
Rochester, MN 55905
Ann Birgin
507 284-8828

---