Overview

Clinical Activity of Metformin With High-dose of Dexamethasone in Relapse Multiple Myeloma

Status:
Unknown status
Trial end date:
2020-02-01
Target enrollment:
0
Participant gender:
All
Summary
This phase II trial study assessing the activity of metformin when given together with high dose of dexamethasone in treating patients with multiple myeloma (MM) that has relapse or refractory to previous treatment. High dose of dexamethasone (HDdexa) is used to treat relapse/refractary patients with myeloma and metformin also demonstrated synergistic activity with dexamethasone to eradicate MM cells in vitro and in vivo. Metformin hydrochloride, used for diabetes, may also help kill tumor cells. Giving dexamethasone with metformin may kill more MM cells and increase the response rate to HDdexa.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Campinas, Brazil
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Metformin
Criteria
Inclusion Criteria:

- Patients over 18 years;

- Multiple myeloma patients relapsed or refractory to two lines prior to treatment [at
least one line using bortezomib or prior treatment with a suitable alkylating agent
(at least six cycles of treatment with alkylating or progressive disease after at
least two cycles of treatment with alkylating or treatment with alkylating received as
part of a stem cell transplant)];

- Patients should have failed (progressive disease at or before 60 days of treatment,
disease progression ≤6 months after achieving partial response or intolerance to
bortezomib) to treatment with bortezomib;

- Patients with oral access to medicines;

- ECOG ≤ 2;

- Blood count: hemoglobin ≥8 g / dL; absolute neutrophil count ≥500 / mm3 and platelet
count ≥30.000 / mm3, glomerular filtration rate (GFR) ≥60ml / min and adequate liver
function (AST or ALT at levels 3x upper limit of normal, bilirubin in levels no
greater than 2x the upper limit of normal, negative pregnancy test before study
initiation or accept contraceptive use.

Exclusion Criteria:

- Patients with known hypersensitivity and / or prior therapy with metformin or its
excipients;

- Diabetes mellitus who require insulin use and other oral hypoglycemic agents; patients
with a history of hyperglycemia induced by steroids can be entered since HbA1C in
screening visit is <8%;

- leptomeningeal or brain metastases symptomatic or untreated, or spinal cord
compression;

- Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus
(HCV) (with the exception treated or cured chronic HBV and HCV infection, who will be
allowed);

- Patients who are using another study medication or who have received drug under study
for less than 4 weeks;

- It is allowed concomitant treatment with bisphosphonates; however, treatment should be
started before the first dose of study therapy;

- it is not allowed to use of all herbal supplements during the study (including, but
not limited to, St. John's wort, kava, None, gingko biloba, dehydroepiandrosterone
[DHEA], or ginseng). megestrol acetate (Megace) or medroxyprogesterone if used as an
appetite stimulant is permitted;

- Uncontrolled situations by intercurrent disease, including, but not limited to,
infection ongoing and active, refractory systemic hypertension, symptomatic congestive
heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric / social
disease that would limit compliance with the requirements of study;

- Previous Neoplasms, except skin cancer for over two years;

- Patients who are pregnant or breastfeeding.

- Any major surgery, extensive radiation therapy, chemotherapy delayed toxicity,
biological therapy, chemotherapy or immunotherapy within 28 days before study.