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

Completed · Phase 2

Conditions studied: Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT01447914
Run by: National Cancer Institute (NCI)
People needed: 16
Starts: 2011-11-01
Expected to finish: 2014-04-01
Last updated by the study team: 2019-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 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

You may not qualify if…

Patients who are receiving any concurrent investigational agent with known or suspected activity against multiple myeloma, or those whose adverse events due to agents administered more than 4 weeks earlier have not recovered to a severity of grade 0 or grade 1
Patients who have known central nervous system involvement with multiple myeloma will be excluded from this clinical trial
Patients who have previously been treated with another agent targeting the HGF/c-Met axis, including either monoclonal antibodies to HGF or c-Met, or small molecule inhibitors of c-Met
Patients with a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to ARQ 197
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, in the opinion of the Principal Investigator
Pregnant or lactating women are excluded from this study
HIV positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ARQ 197; however, HIV seropositive patients with acceptable organ function who meet the patient selection criteria, and who are not on combination antiretroviral therapy, will be eligible
Patients with non-secretory multiple myeloma, active plasma cell leukemia, defined as either having 20% of peripheral white blood cells comprised of CD138+ plasma cells, or an absolute plasma cell count of 2 x 10\^9/L, known amyloidosis, or known POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Patients who have required plasmapheresis and exchange less than 2 weeks prior to initiation of therapy with ARQ 197
Patients with known active hepatitis A, B, and/or C infection
Patients with a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled; patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for > 5 years, and are considered by their physician to be at less than 30% risk of relapse; in addition, patients with basal cell carcinoma of the skin, superficial carcinoma of the bladder, carcinoma of the prostate with a current prostate-specific antigen (PSA) value of < 0.5 ng/mL, or cervical intraepithelial neoplasia will be eligible; finally, patients who are on hormonal therapy for a history of either prostate cancer or breast cancer may enroll, provided that there has been no evidence of disease progression during the previous three years

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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