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Cancer Care

Lymphoma and Multiple Myeloma

Multiple Myeloma

1

Disease Status and/or Stage	Newly Diagnosed Multiple myeloma
Protocol Title	A Phase II Study of Thalidomide (Thalomid®), Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) for Subjects with Newly Diagnosed Multiple Myeloma
PI	Ruben Niesvizky, MD
Contact	Mary Crann, RN 212-746-1480 Or visit: MyelomaCenter.org
Key Eligibility	Newly diagnosed Multiple Myeloma with no anti-myeloma therapy within 14 days prior to initiation of study treatment except for corticosteroids with a maximum allowed dosage equivalent to three pulses of dexamethasone (40mg daily for 4 days equals one pulse). Patients may be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care.
Treatment Overview	Patients will receive the following regimen for a maximum of 6 cycles (1 cycle = 28 days): - Thalidomide (50mg daily for days 1-7, thereafter 100mg daily for days 8-28 of the first 28 day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 for each subsequent cycle) - Clarithromycin (500mg twice daily for each 28 day cycle) - Lenalidomide (25mg daily days 1-21 of every 28 day cycle) - Dexamethasone (40mg daily on day 1, 8, 15, and 22 of each 28 day cycle) - Prophylactic medications, such as medication for thrombosis risk will be given This protocol also includes a maintenance therapy: - Dexamethasone 20mg weekly (days 1, 8, 15, 22 out of a 28 day cycle) - Lenalidomide 25mg daily for days 1-21 out of a 28 day cycle to patients with a creatinine clearance of less than 40cc/minute) - Prophylactic medications, such as aspirin for thrombosis risk, will be continued. Contact Research Nurse for more information or regimen clarification

2

Disease Status and/or Stage	Relapsed or Refractory Multiple myeloma
Protocol Title	Phase 1b Study of the Safety and Pharmacokinetics of Carfilzomib in Subjects with Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function
PI	Ruben Niesvizky, MD
Contact	Mary Crann, RN 212-746-1480 Or visit: MyelomaCenter.org
Key Eligibility	Multiple Myeloma: IgG or IgA, IgE or IgD, light chain disease 4. Relapsed and/or refractory disease after at least one, but no more than 5 prior therapeutic treatments or regimens for multiple myeloma; prior therapeutic treatment regimens may have included bortezomib, lenalidomide, and/or thalidomide, among other agents. Subjects must have been responsive to standard first-line therapy
Treatment Overview	Carfilzomib, 15 mg/m2, will be administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. If 15 mg/m2 is tolerated during Cycle 1, the dose may be increased to 20 mg/m2 for subsequent cycles. Dexamethasone 4 mg PO or IV should be administered prior to each carfilzomib dosing during the first cycle of treatment. A 24-hour urine collection for creatinine clearance, protein clearance, and urine protein electrophoresis (UPEP) will be done prior to dosing.

3

Disease Status and/or Stage	Relapsed Multiple Myeloma
Protocol Title	A Phase I Study of SGN-40 (anti-huCD40 mAb), Lenalidomide (Revlimid®, cc-5013), and Dexamethasone in Patients with Multiple Myeloma (MM)
PI	Ruben Niesvizky, MD
Contact	Mary Crann, RN 212-746-1480 Or visit: MyelomaCenter.org
Key Eligibility	- Pathologic diagnosis of MM - CD40 expression on myeloma cells on a fresh tumor sample as determined by a central laboratory using pre-established guidelines to determine adequate CD40 expression - Patient must have received at least one prior systemic therapy other than single-agent corticosteroids.
Treatment Overview	All study drugs will be started together on Day 1 of Cycle 1. Patients will receive lenalidomide daily via oral administration on Days 1-21. During Cycle 1 only, oral dexamethasone and intravenous SGN-40 will be administered twice during Week 1 (Day 1 and 4) and then once weekly for 3 weeks. Following Cycle 1, patients with no evidence of disease progression and no clinically significant adverse events will be eligible for continued treatment for a maximum of eight cycles of therapy. Patients who achieve a complete response (CR) at any time will be eligible to continue treatment with two cycles beyond CR. For Cycles 2-4, lenalidomide will continue to be given daily on Days 1-21, and dexamethasone and SGN-40 will be given weekly on Days 1, 8, 15, and 22. For Cycles 5-8, lenalidomide and dexamethasone will be given as for Cycles 2-4 but SGN-40 will be given on Days 1, 8, and 15 only.

4

Disease Status and/or Stage	Multiple myeloma
Protocol Title	CALGB 100104: A Phase III Randomized, Double-Blind Study of Maintenance Therapy with CC_5013 (NSC #703813, IND #70116) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma.
PI	Tsiporah Shore, MD
Contact	June Greenberg, RN 212-746-1480
Key Eligibility	Must have active multiple myeloma requiring treatment and have stable disease or be responsive to at least 4 months of induction therapy. No more than 12 months of any prior therapy.
Treatment Overview	Peripheral Blood Stem Cell Transplantation followed by randomization to 10 mg placebo or 10 mg CC05013 arm.

5

Disease Status and/or Stage	Patients who have received primary induction therapy but still have residual disease and for patients with relapsed/refractory disease who are Velcade-naïve
Protocol Title	A Sequential Phase II Trial of the Combination of Bortezomib (VELCADE), Dexamethasone (DECADRON) and Liposomal Doxorubicin (DOXIL) DoVe-D Followed by High Dose Cyclophosphamide in Multiple Myeloma Patients
PI	Ruben Niesvizky, MD
Contact	Mary Crann, RN 212-746-1480 Or visit: MyelomaCenter.org
Key Eligibility	Group A (post-induction therapy) - patients who have received only one prior treatment regimen Group B (>1st line of therapy) - patients with relapsed/refractory multiple myeloma who have received two or more prior treatment regimens Measurable disease as defined by > 1.0 g/dL serum monoclonal protein or > 0.1 g/dL serum free light chains or > 0.2 g/24 hrs urinary M-protein excretion or measurable plasmacytoma(s) No prior treatment with Velcade Adequate renal function (creatinine < 2.5 mg/dL)
Treatment Overview	Velcade will be given twice weekly for two weeks (days 1,4, 8, and 11) followed by a 10-day rest (days 12-21) every 21 days. Decadron will be given orally on days 1-4, 8-11, 15-18, followed by an 3 day rest every 21 days. Doxil will be given once every 21 days beginning on day 4 of Cycle 3 for patients who have less than a PR after 2 cycles, and Cycle 5 for patients who have less than a CR. Mobilization: patients will receive one cycle of Velcade given twice weekly for two weeks (on Days 1, 4, 8 and 11). Along with Velcade high dose cyclophosphamide will be administered on day 8 followed by G-CSF, beginning 24 hours after cyclophosphamide dose and given for a total of ten daily doses.

6

Disease Status and/or Stage	Relapsed or refractory
Protocol Title	A Phase I/II Study of Immunotherapy with hLL1 Administered Twice Weekly for 4 Consecutive Weeks in Patients with Multiple Myeloma
PI	Ruben Niesvizky, MD
Contact	Mary Crann, RN 212-746-1480 Or visit: MyelomaCenter.org
Key Eligibility	For patients with stage II or III secretory multiple myeloma with one or more criteria for measureable disease. Patients must have had at least two prior standard systemic treatment regimens.
Treatment Overview	hLL1 will be administered intravenously twice weekly (days 1, 4, 8, 11, 15, 18, 22, 25) for 4 consecutive weeks. Patients will be followed every 3 months for two years or until disease progression.

7

Disease Status and/or Stage	Relapsed or refractory
Protocol Title	A Phase II Study of VEGF Trap for the Treatment of Relapsed or Refractory Multiple Myeloma
PI	Ruben Niesvizky, MD
Contact	Mary Crann, RN 212-746-1480 Or visit: MyelomaCenter.org
Key Eligibility	For patients with stage IIa or IIIa multiple myeloma with measurable disease defined by serum M protein greater than or equal to 1.0 gm/dl measured by serum protein electrophoresis or free light chain measurement of more than 200 mg/dl and/or urinary M protein excretion greater than or equal to 200 mg/24 hours. Patients must have had 2 or fewer prior therapies. Patient must have normal organ and marrow function.
Treatment Overview	Patients will receive a dose of VEGF Trap by infusion on Day 1 of each 14 day cycle. Patients can receive VEGF Trap until they experience progression of disease or unacceptable adverse events.

8

Disease Status and/or Stage	Relapsed or Refractory Multiple Myeloma
Protocol Title	A Phase I Open Label Study of Noscapine HCI (CB3304) in patients with Relapsed or Refractory Multiple Myeloma
PI	Ruben Niesvizky, MD
Contact	Mary Crann, RN 212-746-1480 Or visit: MyelomaCenter.org
Key Eligibility	Evidence of relapsed or refractory disease following greater than or equal to four (4) lines of therapy, such as bortezomib, immunomodulatory, and alkylating agents.
Treatment Overview	Each subject will receive a dose according to their dose level assignment (1000-3000 mg/day). On Cycle 1 Day 1, one dose of Noscapine HCI (CB3304) will be administered orally in the morning after an overnight fast. The study medication will resume on Cycle 1 Day 2. Noscapine HCI (CB3304) will be administered either one hour before or two hours after food intake, at an interval approximately every 12 hours (twice daily) on a daily basis.

9

Disease Status and/or Stage	Relapsed or Refractory Multiple Myeloma
Protocol Title	Phase 1/2 Open-Label Study of the Safety and Efficacy of PD 0332991 In Combination with Bortezomib and Dexamethasone in Patients with Refractory Multiple Myeloma
PI	Ruben Niesvizky, MD
Contact	Mary Crann, RN 212-746-1480 Or visit: MyelomaCenter.org
Key Eligibility	Relapsed or Refractory Multiple Myeloma after at least 2 prior therapies. All previous therapies for cancer must be discontinued for at least 4 weeks (2 weeks for lenalidomide or thalidomide) before study entry.
Treatment Overview	PD 0332991 will be given orally, starting on Day 1 of each cycle, once a day for 3 weeks (21 days) followed by one week (7 days) without treatment. Bortezomib and dexamethasone will be administered on Days 8, 11, 15, and 18 of Cycles 1 through 10. One cycle is defined as 4 weeks (28 days). The maximum treatment period will be 10 cycles or 280 days.

10

Disease Status and/or Stage	Untreated Multiple Myeloma
Protocol Title	Phase 3b Study of Three Treatment Regimens in Subjects with Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Tranplantation: VELCADE (Bortezomib), Thalidomide, and Dexamethasone (VTD) versus VELCADE and Dexamethason (VD) versus VELCADE, Melphalan, and Prednisone (VMP)
PI	Ruben Niesvizky, MD
Contact	Mary Crann, RN 212-746-1480 Or visit: MyelomaCenter.org
Key Eligibility	- Patients cannot be a candidate for high-dose chemotherapy and stem cell transplantation (HDT/SCT). - Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage. - Cannot have MGUS or Waldenstrom's disease - Cannot currently or previously be treated with any systematic therapy for multiple myeloma.
Treatment Overview	Patients in all 3 treatment groups will be treated for up to approximately one year, which includes eight 21-day treatment cycles during the Induction Treatment period: - VELCADE and Dexamethasone (VD), or - VELCADE, Thalidomide and Dexamethasone (VTD), or - VELCADE, Melphalan, and Prednisone (VMP) and five 35-day treatment cycles during the Maintenance Treatment period (maintenance=VELCADE only.)

11

Disease Status and/or Stage	Relapsed or Refractory Multiple Myeloma
Protocol Title	Phase 1b Multicenter Dose Escalation Study of Carfilzomib with Lenalidomide and Dexamethasone for Safety and Activity in Relapsed Multiple Myeloma
PI	Ruben Niesvizky, MD
Contact	Mary Crann, RN 212-746-1480 Or visit: MyelomaCenter.org
Key Eligibility	- Relapsed or progressive Multiple Myeloma after at least one but no more than three prior therapeutic treatments or regimens (can include bortezomib, lenalidomide, and/or thalidomide, among other agents); must be able to tolerate bortezomib & lenalidomide. - No corticosteriod therapy in a dose equivalent to dexamethasone >1.50 mg/day or prednisone >10 mg/day within 3 weeks prior to first dose; no POEMS syndrome, Plasma Cell leukemia, or Waldenstrom's; no chemotherapy with approved/investigational anti-cancer therapeutics within 3 weeks prior to first dose.
Treatment Overview	Patients will receive carfilzomib, in combination with lenalidomide and dexamethasone, and be evaluated for response after 4 cycles of treatment. Subjects without disease progression or unacceptable toxicity will receive 4 additional full cycles of treatment. Subjects who achieve a response to treatment after 8 cycles may continue to receive up to 8 additional maintenance treatment cycles (for a total of 16 treatment cycles), as long as they do not show disease progression or unacceptable toxicity.

12

Disease Status and/or Stage	Relapsed and Refractory Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Waldenström’s Macroglobulinemia, Multiple Myeloma, Chronic Lymphocytic Leukemia
Protocol Title	A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Intravenous Doses of the Proteasome Inhibitor PR-171 in Patients with Hematological Malignancies: Four Week Cycle
PI	Richard Furman, MD
Contact	Patricia Glynn, RN 212-746-6738
Key Eligibility	Histologically confirmed diagnosis of a hematologic malignancy who is relapsed or refractory to at least two prior therapies. Patient must have adequate blood work including: Total white blood cell (WBC) count >2,000/mm3, absolute neutrophil count (ANC) >1000/mm3, hemoglobin >8.0 g/dL, and platelet count >50,000/mm3.
Treatment Overview	This clinical trial is a Phase 1, open-label, dose-escalating design followed by a dose expansion period. Patients will receive a minimum of 20 mg/m2 of Carfilzomib on days 1, 2, 8, 9, 15, and 16 in a 28-day cycle. Patients may continue to receive study treatment as long as stable disease or clinical benefit and absence of unacceptable toxicity is demonstrated.

13

Disease Status and/or Stage	Relapsed or Refractory Multiple Myeloma
Protocol Title	A Phase II Study of Dexamethasone (Decadron®), Thalidomide (Thalomid®), and Lenalidomide (Revlimid®) for Subjects with Relapsed or Refractory Multiple Myeloma
PI	Ruben Niesvizky, MD
Contact	Mary Crann, RN 212-746-1480 Or visit: MyelomaCenter.org
Key Eligibility	- Relapsed or refractory myeloma, progression of disease either after prior therapy or lack of response to currently used therapy. - Prior treatment with prior lenalidomide and thalidomide as single agents or in combination with dexamethasone, but not in combination with each other. - No anti-myeloma therapy within 14 days prior to initiation of study treatment. Patients may be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care.
Treatment Overview	All patients will receive thalidomide, lenalidomide, and dexamethasone in 28 day cycles according to the following schedule: Dexamethasone (Decadron®) will be given orally at a dose of 40 mg on days 1-4, 9-12, 17-20, and 25-28 of each 28 day cycle. Lenalidomide (Revlimid®) will be given orally at a dose of 25 mg daily beginning on day 1 and ending on day 21 on each 28 day cycle. Thalidomide (Thalomid®) will be given orally at a dose of 50mg daily for days 1-7 of cycle 1 and then changed to 100mg daily for days 8-28. Patients will take thalidomide at a dose of 100mg orally on days 1-28 of subsequent cycles.

Last updated: March 20, 2009

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