Multiple Myeloma in Relapse Clinical Trial
Official title:
A Phase II Study of Pomalidomide, Daily Low Dose Oral Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma
This study is being done to learn more about the drug, pomalidomide and to gather data on its
safety and side effects when used in combination with commercially available cyclophosphamide
and dexamethasone. This combination is considered experimental and has not been approved by
the FDA.
Pomalidomide is a third generation immunomodulatory (IMiDs) agent, which is a more potent
version of thalidomide and lenalidomide drugs that have been approved by the United States
Food and Drug Administration [FDA] for the treatment of MM. In February 2013, pomalidomide
was also approved by the FDA for patients with MM who have had more than 2 types of therapy.
Pomalidomide is taken orally as capsules, and cyclophosphamide and dexamethasone are also
taken orally as tablets in this study. Cyclophosphamide and dexamethasone are commercially
available and are often used in combination with other drugs to treat Multiple Myeloma.
Preliminary data from both the laboratory and patient studies suggest that this combination
of drugs is more effective than pomalidomide and dexamethasone alone. However, the regimen
being used in this study, which consists of daily cyclophosphamide, also permits support of
low blood counts with either injections or transfusions as needed.
This is an open label, single center, phase II study of a combination of pomalidomide, daily
low dose oral cyclophosphamide, and dexamethasone in patients with relapsed/refractory
multiple myeloma. The three oral drugs will be given in 28-day cycles: Pomalidomide 4 mg
daily x 21 days; cyclophosphamide 50 mg BID x 21 days; and dexamethasone 40 mg weekly x 3 (20
mg weekly if the patient aged ≥ 75 years old). Subjects meeting eligibility criteria with ANC
< 1000/µL and platelet count < 50,000/µL will start at dose level -1 of both pomalidomide (3
mg daily) and cyclophosphamide (50 mg daily). G-CSF and platelet transfusion support is
permitted if needed.
Dose reduction for hematologic toxicity will begin with cyclophosphamide and then
subsequently alternate with pomalidomide until a subject cannot tolerate dose level -2 of
both agents - in which case subject would come off study. If subject has 2 or more concurrent
toxicities that are potentially attributable to both agents (e.g. hematologic toxicity) then
dose modification guidelines will be followed with dose reduction being done sequentially
with one agent at a time, unless in the opinion of the investigator, both agents required
concurrent dose reduction.
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