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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 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.

3

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.

4

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.

5

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.

6

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.

7

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.

8

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.

9

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.)

10

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.

11

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.

12

Disease Status and/or Stage B-cell non-Hodgkin's lymphoma (including CLL/SLL and WM), multiple myeloma, or Castleman's Disease
Protocol Title Phase I Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) Administered Biweekly as an Intravenous Infusion in Subjects with Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease
PI Richard Furman, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility Patients with B-cell non-Hodgkin's lymphoma (including CLL/SLL and WM), multiple myeloma, or Castleman's Disease who have progressed on or after standard therapy.
Treatment Overview Patients will receive Interleukin-6 at various times and doses depending on what cohort they are enrolled in. The maximum number of doses will be once weekly for 7 weeks.

 

 
Last updated: July 30, 2008
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