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Phase 2 N=16 Treatment

Tivantinib in Treating Patients With Relapsed, or Relapsed and Refractory Multiple Myeloma

Refractory Multiple Myeloma

Enrolled (actual)
16
Serious AEs
50.0%
Results posted
Mar 2015
Primary outcome: Primary: Overall Response Rate (ORR) — 4; 7; 5 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Tivantinib (Drug); Diagnostic laboratory biomarker analysis (Other); Questionnaire administration (Other); Quality-of-life assessment (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Mar 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Response Rate (ORR)
4; 7; 5
PRIMARY
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
1; 2; 1; 4; 1; 1
SECONDARY
Time to Next Treatment (TTNT)
4

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.

Eligibility Criteria

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%
  • 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 chain ratio
  • Patients must have had at least one, but not more than four prior lines of therapy for their disease, with lines of therapy being separated by the presence of documented disease progression; using this definition, treatment with induction therapy, followed by high-dose chemotherapy and autologous stem cell transplantation, and finally by maintenance therapy, would constitute one line, provided that multiple myeloma did not meet criteria for progression at any time during this period
  • Patients with relapsed disease will be considered to be those who have had progression, as defined above, off of any therapy, and who completed their therapy more than 60 days prior to the finding of progression; patients with relapsed and refractory disease will be considered to be those who have had progression, as defined above, while still on their last line of therapy, or who progressed within 60 days of finishing their most recent therapy
  • Patients must have completed their most recent drug therapy directed at multiple myeloma in the following time frames:
  • Chemotherapy, biological therapy, immunotherapy, or an investigational therapy at least 3 weeks prior to starting c-Met inhibitor ARQ197
  • Corticosteroids at least 3 weeks prior to starting ARQ 197, except for a dose equivalent to dexamethasone of no greater than 4 mg/day
  • Nitrosoureas, nitrogen mustards, mitomycin C, or monoclonal antibodies at least 6 weeks prior to starting ARQ 197
  • Autologous stem cell transplantation at least 12 weeks prior to starting ARQ 197
  • Allogeneic stem cell transplantation at least 24 weeks prior to starting ARQ 197, and these patients must also not have moderate to severe active acute or chronic graft-versus-host disease
  • Patients must be willing and able to provide voluntary written informed consent, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky >= 60%)
  • Absolute neutrophil count (ANC) >= 1, 000 cells/mm^3 without growth factors within 1 week of the initiation of treatment
  • Total white blood cell count (WBC) >= 2,000 cells/mm^3 without growth factors within 1 week of the initiation of treatment
  • Hemoglobin >= 8 g/dL without red blood cell transfusions within 2 weeks of the initiation of treatment
  • Platelet counts of >= 100, 000 cells/mm^3 for patients who have bone marrow plasmacytosis of = 50,000 cells/mm^3 for patients who have bone marrow plasmacytosis of >= 50%
  • Total bilirubin = = 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula
  • Patients must have evidence of adequate cardiac function, as defined by the following:
  • Absence of New York Heart Association (NYHA) class II,
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01447914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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