Tivantinib in Treating Patients With Relapsed, or Relapsed and Refractory Multiple Myeloma (NCT01447914) | Clinical Trial Compass
CompletedPhase 2
Tivantinib in Treating Patients With Relapsed, or Relapsed and Refractory Multiple Myeloma
United States16 participantsStarted 2011-11
Plain-language summary
This phase II trial studies the side effects and how well tivantinib works in treating patients with relapsed, or relapsed and refractory multiple myeloma. Tivantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have been previously diagnosed with histologically or cytologically confirmed symptomatic multiple myeloma, which requires the presence of all three of the following International Myeloma Working Group criteria, except as noted:
* Clonal bone marrow plasma cells \>= 10%
* A monoclonal protein in either serum or urine
* Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder (to include one of the following):
* Hypercalcemia (corrected calcium \> 2.75 mmol/L or 11.5 mg/dL)
* Renal insufficiency attributable to myeloma (serum creatinine \> 1.9 mg/dL)
* Anemia; normochromic, normocytic with a hemoglobin value \>= 2 g/dL below the lower limit of normal, or a hemoglobin or \< 10 g/dL
* Bone lytic lesions, severe osteopenia, or pathologic fractures
* Patients with a biopsy-proven plasmacytoma and either a serum or urine monoclonal protein will also be considered to have met the diagnostic criteria for multiple myeloma in the absence of clonal marrow plasmacytosis of \>= 10%
* Patients must have measurable disease, as defined by at least one of the following:
* Serum monoclonal protein level \>= 0.5 g/dL for immunoglobulin (Ig)G, IgA, or IgM disease
* Monoclonal protein or total serum IgD \>= 0.5 g/dL for IgD disease
* Urinary M-protein excretion of \>= 200 mg over a 24-hour period
* Involved free light chain level \>= 10 mg/dL, along with an abnormal free light…
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: Up to 30 days
2
Toxicities of Single Agent Tivantinib: Grade 3 Nonhematologic or Grade 4 Hematologic Toxicities According to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4