Phase 2
N=48
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma
Recurrent Plasma Cell Myeloma · Refractory Plasma Cell Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00450814 ↗Enrolled (actual)
48
Serious AEs
12.8%
Results posted
Dec 2019
Primary outcome: Primary: Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclophosphamide (Drug); Laboratory Biomarker Analysis (Other); Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter (Biological); Pharmacological Study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Maximum Tolerated Dose (MTD) (Phase I) |
6 | — |
| PRIMARY Proportion of Confirmed Response, Defined as a Partial Response (PR) or Better (Phase II) |
— | — |
| SECONDARY Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase I) |
38; 25 | — |
| SECONDARY Number of Patients With Clinical Responses (Phase I) |
1; 0 | — |
| SECONDARY Overall Survival (Phase II) |
12.0 | — |
| SECONDARY Time to Progression (TTP) (Phase II) |
1.48 | — |
| SECONDARY Progression-free Survival (Phase II) |
1.48 | — |
| SECONDARY Progression-free Survival (Phase II) |
1.48 | — |
| SECONDARY Progression-free Survival (Phase II) |
1.48 | — |
| SECONDARY Failure-free Survival (Phase II) |
1.4783 | — |
| SECONDARY Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase II) |
73.3 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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) = = 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00450814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.