RO4929097 After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
Withdrawn before enrolling · Phase 2
Conditions studied: DS Stage I Plasma Cell Myeloma, DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
In brief
This phase II clinical trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 (RO4929097) after autologous stem cell transplant works in treating patients with multiple myeloma. Giving chemotherapy, such as melphalan, before autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Before treatment, stem cells are collected from the patient's blood and stored. After chemotherapy, the stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. RO4929097 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving RO4929097 after autologous stem cell transplant may kill more cancer cells.
Key facts
- Study ID
- NCT01251172
- Run by
- National Cancer Institute (NCI)
- People needed
- 0
- Starts
- 2010-12-01
- Last updated by the study team
- 2017-09-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have a diagnosis of multiple myeloma as defined below with staging based on the International Staging System:
- Multiple myeloma - all three required (Note: these criteria identify stage 1B and stages II and IIIA/B myeloma by Durie/Salmon stage; stage 1A becomes smoldering or indolent myeloma):
- Monoclonal plasma cells in the bone marrow ≥ 10% and/or presence of a biopsy-proven plasmacytoma
- Monoclonal protein present in the serum and/or urine (if no monoclonal protein is detected [non-secretory disease], then >= 30% monoclonal bone marrow plasma cells and/or biopsy-proven plasmacytoma is required)
- Myeloma-related organ dysfunction (1 or more) (a variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy; such dysfunction is sufficient to support classification as myeloma if proven to be myeloma related):
- Calcium elevation in the blood (serum calcium > 10.5 mg/L or upper limit of normal)
- Renal insufficiency (serum creatinine > 2mg/dL)
- Anemia (hemoglobin < 10 g/dL or 2 g < normal)
- Lytic bone lesions or osteoporosis (if a solitary [biopsy-proven] plasmacytoma or osteoporosis alone [without fractures] are the sole defining criteria, then > 30% plasma cells are required in the bone marrow)
- Patients must have measurable disease
- Patients with non-secretory multiple myeloma will be eligible only if the baseline serum free light chain level is elevated (>= 10 mg/dL)
- For therapeutic treatment with RO4929097, patients must have peripheral blood stem cell collection of >= 4.0 x 10\^6 cells/kg (patient's ideal body weight)
- ECOG performance status =< 2, Karnofsky >= 60%
- Estimated life expectancy of at least 12 weeks
- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 9.0 g/dL
- NOTE: Patients should not require chronic supportive growth factor administration or transfusions to meet treatment eligibility criteria (e.g., G-CSF for ANC eligibility)
- Serum creatinine =< 2.0 mg/dL OR a measured creatinine clearance by 24-hour urine collection >= 40 mL/min (a calculated creatinine clearance by Cockcroft-Gault formula is acceptable in lieu of a measured value)
- Total bilirubin within normal institutional limits
- AST (SGOT)/ALT SGPT) =< 2.5 X institutional ULN
- Patients with uncontrolled electrolyte abnormalities including hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia, defined as less than the lower limit of normal for the institution despite adequate electrolyte supplementation, are excluded from this study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry, for the duration of study participation, and for at least 12 months post-treatment
Where it is running
- Moffitt Cancer Center — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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