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.

Please see intervention description for Bortezomib (Velcade)

21 day-cycle Induction therapy:bortezomib 1.3 mg/m2 (I.V. Days 1, 4, 8, and 11), then 10-day rest period. DOXIL 30 mg/m2 given after bortezomib (I.V. infusion Day 4 of each cycle). Dexamethasone 40 mg PO on days 1-4,8-11 and 15-18 during the first cycle. Subsequent 3 cycles, dexamethasone 40 mg PO given on days 1-4 and 11-14. Patients who don't progress may undergo elective stem cell mobilization, stem cell collection and cryopreservation. Patients will then receive post-induction therapy 1.5 mg/m2 bortezomib days 1, 8, and 15 I.V. + cyclophosphamide 300 mg/m2 PO weekly + prednisone 100 mg PO on alternate days for 8 monthly 28 day cycles.Maintenance therapy with weekly 40 mg dexamethasone (days 1, 8, 15 and 22) every month until disease progression occurs.

Bortezomib

Cross Cancer Institute 11560 University Ave

CancerCare Manitoba 675 McDermot Ave.

Queen Elizabeth II Health Sciences Centre.

London Regional Cancer Program 790 Commissioners Road East

The Ottawa Hospital

Princess Margaret Hospital

Saskatoon Cancer Centre 20 Campus Drive

Combination Bortezomib-containing Regimens in Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma

An Open-label Phase II Study of the Efficacy of Combination Bortezomib-containing Regimens in the Treatment of Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma

Measured from the date of enrollment to the date of disease progression. Otherwise, censored at the time of last disease assessment. Responses were assessed using the International Myeloma Working Group criteria, involving a modified version of the European Group for Blood and Marrow Transplantation (EBMT) criteria, where the category of stringent complete response (sCR) was included for patients with normalization of the free light chain ratio.10,11 Bone marrow aspirate and biopsy were obtained routinely after induction therapy to confirm CR or sCR. Serum free light chain assay and serum and/or urine electrophoresis were performed monthly; immunofixation was performed when confirmation of very good partial response (VGPR), CR, or sCR was necessary.

Objective response after completing induction therapy and until disease progression.

PFS was measured from the date of enrollment to the date of disease progression or death from any cause, otherwise censored at the time of last disease assessment.

Patients were followed monthly until disease progression and subsequently every six months for up to five years to assess OS.

Safety analyses focused on hematological and non-hematological adverse events of all grades. Toxicity was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0)

Un-identified data will be submitted to the DSMB for review. Sites will be provided with the DSMB letter after a meeting has been held to review data.

plasmacytoma/tyrosine

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

Combination Bortezomib-containing Regimens in Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma

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