A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (NCT02886065) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM
United States19 participantsStarted 2017-03-07
Plain-language summary
This research study is studying a targeted therapy as a possible treatment for Smoldering Multiple Myeloma.
The following intervention will be involved in this study:
* Lenalidomide
* Citarinostat (CC-96241)
* PVX-410
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patient has confirmed SMM according to a definition derived from the International Myeloma Working Group (IMWG) definition (International Working Group, 2003): serum M-protein ≥3 g/dL or BMPC \>10%, or both, along with normal organ and marrow function (CRAB) within 4 weeks before baseline.
* C: Absence of hypercalcemia, evidenced by a calcium \<10.5 mg/dL.
* R: Absence of renal failure, evidenced by a creatinine \< 1.5 mg/dL (177 µmol/L) or calculated creatinine clearance (using the Modification of Diet in Renal Disease \[MDRD\] formula) \>50 mL/min.
* A: Absence of anemia, evidenced by a hemoglobin \>10 g/dL.
* B: Absence of lytic bone lesions on standard skeletal survey.
* Patient is at higher than average risk of progression to active MM, defined as having 2 or more of the following features:
* Serum M-protein ≥3 g/dL.
* BMPC \>10%.
* Abnormal serum FLC ratio (0.26-1.65).
* Patient is aged 18 years or older.
* Patient has a life expectancy of greater than 6 months.
* Patient is HLA-A2+
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Patient has adequate bone marrow function, evidenced by a platelet count ≥75×109/L and an absolute neutrophil count (ANC) ≥1.0×109/L within 2 weeks before baseline.
* Patient has adequate hepatic function, evidenced by a bilirubin ≤2.0 mg/dL and an alanine transaminase (ALT), and aspartate transaminase (AST) ≤2.5×ULN within 2 weeks before baseline.
* If of child-b…
What they're measuring
1
Safety And Tolerability Of The PVX-410 Tumor Vaccine Regimen