Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia

Completed · Phase 1

Conditions studied: Anemia, Fatigue, Fever, Lymphadenopathy, Lymphocytosis, Night Sweats, Recurrent Chronic Lymphocytic Leukemia, Recurrent Plasma Cell Myeloma, Refractory Chronic Lymphocytic Leukemia, Refractory Plasma Cell Myeloma, Splenomegaly, Thrombocytopenia, Weight Loss

In brief

This pilot clinical trial studies the side effects and best dose of metformin hydrochloride and ritonavir in treating patients with multiple myeloma or chronic lymphocytic leukemia that has returned after a period of improvement or has not responded to treatment. Metformin hydrochloride and ritonavir may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT02948283

Run by

City of Hope Medical Center

People needed

3

Starts

2017-09-05

Expected to finish

2017-12-01

Last updated by the study team

2021-02-12

Who can join

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

You may qualify if…

• All subjects must have the ability to understand and the willingness to sign a written informed consent
• Life expectancy of > 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• FOR PATIENTS WITH MULTIPLE MYELOMA (MM):
• Diagnosis of multiple myeloma
• Patients with MM must have measurable disease, defined as one or more of the following:
• Serum M-protein >= 0.5 g/dL
• Urine M-protein >= 200 mg/24 hr
• Serum immunoglobulin free light chain (FLC) >= 100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kappa to lambda FLC ratio
• IgA patients must have serum quantitative immunoglobulin >= 750 mg/dL
• Patients with oligosecretory or non-secretory disease must have a documented abnormal free light chain ratio (normal value 0.26 to 1.65) or a value beyond the laboratory calculation range
• Disease must be refractory or relapsed after >= 3 prior regimens (induction therapy and stem cell transplant +/- maintenance will be considered as one regimen)
• FOR PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL):
• Diagnosis of CLL without the following: Richter's transformation, prolymphocytic leukemia (PLL), small lymphocytic lymphoma (SLL)
• Measurable disease, defined as one or more of the following:
• Lymphocytosis >= 5000 in peripheral blood
• Measurable lymph nodes > 1.5 cm on palpation and/or computed tomography (CT) scan
• Organomegaly by physical exam and/or CT scan
• Active disease per International Workshop on Chronic Lymphocytic (IWCLL) 2008 criteria, as defined as one of the following:
• Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
• Massive (i.e., at least 6 cm below the left costal margin) or progressive or symptomatic splenomegaly
• Massive nodes (i.e., at least 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
• Progressive lymphocytosis with an increase of more than 50 percent over a two-month period or lymphocyte doubling time (LDT) of less than six months; LDT can be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of two weeks over an observation period of two to three months; in patients with initial blood lymphocyte counts of less than 30 x 10\^9/L (30,000/L), LDT should not be used as a single parameter to define a treatment indication; in addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (e.g., infection) should be excluded
• Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy
• Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs:

You may not qualify if…

• Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period
• Use of a protease inhibitor for any indication within three months prior to start of study treatment
• Current or planned use of prohibited meds
• Liver disease, except Gilbert's syndrome, liver involvement by CLL or MM, or stable chronic liver disease per investigator's assessment
• Current pancreatitis
• History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to metformin, ritonavir or any of their ingredients
• Non-hematologic malignancy within the past 3 years aside from the following exceptions:
• Adequately treated basal cell or squamous cell skin cancer
• Carcinoma in situ of the cervix
• Prostate cancer < Gleason grade 6 with a stable prostate-specific antigen test (PSA)
• Successfully treated in situ carcinoma of the breast
• Clinically significant cardiac disease, including:
• >= Grade 2 myocardial infarction within 6 months prior to day 1 of protocol therapy
• Unstable or uncontrolled disease condition relating to or affecting cardiac function (e.g. unstable angina, congestive heart failure, New York Heart Association Class III-IV) within 6 months prior to day 1 of protocol therapy
• >= Grade 2 uncontrolled cardiac arrhythmia
• Clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or the patient's ability to give informed consent
• Women who are currently or planning to breastfeed during protocol treatment
• Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, uncontrolled intercurrent illness etc.
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Where it is running

• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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