Clinical Trials

Safety and Tolerability Study of SNS01-T in Relapsed or Refractory Multiple Myeloma, Mantle Cell Lymphoma, or Diffuse Large B Cell Lymphoma

Location:

Rochester,  MN

Trial status:

Open for Enrollment

Why is this study being done?

The main purpose is to test the safety and tolerability of SNS01-T. The first group of patients with relapsed or refractory multiple myeloma will be given a relatively low dose. If tolerated, a second group will receive a higher dose. If tolerated by the second group, a third and then a fourth group will receive higher doses. Treatment-related adverse events (side effects), changes in vital signs, physical examination, and laboratory values will be monitored. Patients will receive twice weekly infusions for 6 weeks and then will be followed monthly for 6 months. A secondary purpose is to explore whether SNS01-T is an effective treatment for multiple myeloma, mantle cell lymphoma and diffuse large B cell lymphoma.

Who is eligible to participate?

Inclusion Criteria:

1. MCL and DLBCL patients must have had their diagnosis confirmed histologically. Multiple myeloma patients must have been diagnosed with multiple myeloma by having met all three of the following IMWG criteria:

- Clonal bone marrow plasma cells >10%

- Presence of serum and/or urinary M-protein

- Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically, one or more of the following:

- Hypercalcemia: serum calcium >11.5 mg/100 mL

- Renal insufficiency: serum creatinine >2mg/dL

- Anemia: normochromic, normocytic with a hemoglobin value >2 g/100 mL below the lower limit of normal or a hemoglobin value <10 g/100 mL

- Bone lesions: lytic lesions, severe osteopenia, or pathologic fractures

2. MCL and DLCBL patients must have measurable disease defined as at least one lesion that can be accurately measured for response in at least two perpendicular dimensions. Multiple myeloma patients must have measurable disease defined by the following:

- Serum M-protein ≥1g/dL or urine M-protein ≥ 200 mg/24 hours by protein electrophoresis

- If neither serum nor urine M-protein meet the criteria above, then kappa or lambda serum FLC must be ≥10 mg/dL accompanied by an abnormal kappa to lambda ratio (<0.26 or >1.65) (Serum FLC should only be used for patients without measurable serum or urine M-protein spike.)

3. Have relapsed or refractory disease after two or more prior treatment regimens, each of which may have consisted of either single or multiple therapies. The investigators will ensure that patients have had the benefit of standard treatments before considering the SNS01-T clinical trial.

4. Be at least 2 weeks beyond the last therapy and have recovered from acute toxicities of prior therapies

5. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3

6. Have life expectancy of at least 3 months

7. Be ≥18 years of age and willing to provide written informed consent

8. Temporarily or permanently reside within 2 hours travel time from a study site

9. For women and men of childbearing potential, have used effective contraceptive methods for at least 4 weeks prior to dosing and agree to continue using such methods during the study, and for at least 4 weeks after completing the study

10. For women of childbearing potential, have a negative serum pregnancy test within 24 hours before the initiation of SNS01-T therapy

11. Have an absolute neutrophil count >1,000/mm3

12. Have a platelet count >50,000/mm3

13. Have total bilirubin <2.0 mg/dL

14. Have aspartate aminotransferase and alanine aminotransferase <3 times the upper limit of normal

15. Have serum creatinine ≤2.5 times the upper limit of normal

16. Have hemoglobin ≥8.5 g/dL

Exclusion Criteria:

1. Have presence of nonsecretory myeloma

2. Have evaluable disease only (myeloma patients)

3. Have New York Heart Association Class III-IV heart failure classification

4. Have uncontrolled autoimmune hemolysis or thrombocytopenia

5. Have CNS or leptomeningeal disease

6. Have an active infection or serious comorbid medical condition

7. Be receiving other concurrent anticancer agents or therapies

8. Be receiving other concurrent investigational therapies or have received investigational therapies within 4 weeks of screening

9. Be eligible to receive any other standard therapy available that is known to extend life expectancy

10. Be receiving steroids unless they are stable doses of steroids equivalent to 20 mg of prednisone or less, or are steroids administered topically or by inhalation.

11. Be receiving or have received heparin therapeutically within two days before and after treatment with SNS01-T

12. Be pregnant or nursing

Last updated: 12/03/2012

NCT ID:

NCT01435720