Ruxolitinib Oral Tablet [Jakafi] at 5mg, 10mg or 15mg BID, Lenalidomide Oral at 5mg or 10mg QD and Methylprednisolone Oral at 40mg QOD. (Dose varies during dose escalation portion of the study)

Subject will receive Ruxolitinib Oral Tablet [Jakafi] at 15mg BID, and Methylprednisolone at 40mg QOD until disease progression. Lenalidomide at 10mg QD will be added to the treatment (Ruxolitinib, Methylprednisolone) once disease progression was confirmed.

Multiple Myeloma

Ruxolitinib will be administered on days 1-28 of the treatment cycle.

Ruxolitinib Oral Tablet [Jakafi]

Lenalidomide will be administered on Days 1-21 of the treatment cycle.

Lenalidomide

Methyl-prednisolone will be administered on Days 1-28 of the treatment cycle.

Methylprednisolone

Global Oncology, Inc.

Comprehensive Blood and Cancer Center

California Cancer Associates for Research & Excellence (cCARE)

Compassionate Care Research Group, Inc.

Robert A. Moss, M.D., F.A.C.P., Inc.

Pacific Cancer Care

Sansum Clinic- Ridley-Tree Cancer Center

James R. Berenson M.D. Inc.

Millennium Oncology Research Clinic

Regional Cancer Care Associates (RCCA) MD, LLC

A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients

MTD will be determined by measuring incidence of the dose-limiting toxicities (DLTs) per dose level, of ruxolitinib in combination with steroids and lenalidomide for MM patients currently with progressive disease.

Safety will be measured by counting the occurrence of adverse events throughout the study, graded via Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 criteria

Overall response rate (ORR) is defined as CR + VGPR + PR

Clinical benefit rate is defined as ORR + MR

Progression-free survival will be measured in months as the time from initiation of therapy to progressive disease or death from any cause, whichever occurs first

Time to response, defined as the time from the initiation of therapy to the first evidence of confirmed clinical benefit defined as > minimal response (MR, including patients who achieved a complete response (CR), very good partial response (VGPR), partial response (PR), or MR

Duration of response, defined as the time (in months) from the first response to progressive disease

Overall survival, defined as the time (in months) from initiation of therapy to death from any cause or last follow-up visit

Response to initial therapy (ruxolitinib and methylprednisolone alone) will be compared to the response to therapy with addition of lenalidomide (ruxolitinib, lenalidomide, methylprednisolone)

Oncotherapeutics

Incyte Corporation

There are 3 study parts: Dose escalation and expansion (Study Part 1), Ruxolitinib/Methylprednisolone Arm (Study Part 2), and Expanded Eligibility Criteria (Study Part 3).
The first 49 subjects will be enrolled into the Ruxolitinib, Lenalidomide and Methylprednisolone treatment arm (Study Part 1).
Subjects in Study Part 2 will receive Ruxolitinib and Methylprednisolone until confirmed disease progression. Lenalidomide will be added to the treatment once disease progression is confirmed.
Subjects in Study Part 3 will receive Ruxolitinib, Lenalidomide and Methylprednisolone treatment.
The study will enroll Part 2 and Part 3 simultaneously. If a patient meets eligibility criteria for Part 2 and Part 3, patient will be enrolled in Part 2 until Part 2 enrollment is complete.

AdHER DC vaccine administered at escalating doses

AdHER DC vaccine administered at a next lower dose or the highest dose

AdHER DC vaccine administered at Dose Level 1

AdHER DC vaccine administered at Arm 1 MTD

Breast Neoplasms

Breast Cancer

Adenocarcinomas

Metastatic Solid Tumors Characterized by HER2/Neu Expression

Autologous AdHER2 transduced dendritic cell vaccine manufactured under GMP conditions from cryopreserved patient monocytes here at the NIH CC DTM. Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16 and 24 of the study.

AdHER2/neu DC Vaccine

National Institutes of Health Clinical Center, 9000 Rockville Pike

Ad/HER2/Neu Dendritic Cell Cancer Vaccine Testing

A Phase I Study of an Adenoviral Transduced Autologous Dendritic Cell Vaccine Expressing Human HER2/Neu ECTM in Adults With Tumors With 1-3+ HER2/Neu Expression

Determine an approximate estimate of the vaccine immunogenicity.

obtain a preliminary estimate of the proportion of patients who may experience tumor shrinkage or stabilization that is sufficient by modified immune response related criteria (irRC) to be considered stable disease, a partial response or better.

bone neoplasms/tyrosine

A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Ad/HER2/Neu Dendritic Cell Cancer Vaccine Testing

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