Hydroxychloroquine, Cyclophosphamide, Dexamethasone, and Sirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
Completed · Phase 1
Conditions studied: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
In brief
This phase I trial studies the side effects and best dose of hydroxychloroquine when given together with cyclophosphamide, dexamethasone, and sirolimus in treating patients with multiple myeloma that has come back after a period of improvement or does not respond to treatment. Biological therapies, such as hydroxychloroquine, may stimulate the immune system in different ways and stop cancer cells from growing. Sirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Giving hydroxychloroquine together with sirolimus, cyclophosphamide, and dexamethasone may be a better treatment for multiple myeloma.
Key facts
- Study ID
- NCT01689987
- Run by
- OHSU Knight Cancer Institute
- People needed
- 18
- Starts
- 2012-09-01
- Last updated by the study team
- 2017-09-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed multiple myeloma
- Documented relapse or persistent disease after at least 1 prior therapy containing both bortezomib and lenalidomide; or at least 2 prior therapies containing bortezomib in one and lenalidomide in the other, or if intolerant of bortezomib and/or lenalidomide; prior autologous and allogeneic bone marrow transplantation are allowed
- Need for further treatment for myeloma, as determined by the patient's treating physician; this is defined as progression of clinical features (worsening anemia, renal function, bone disease, hypercalcemia, recurrent infections, and constitutional symptoms) OR biochemical progression (increasing M-spike in serum or urine, involved serum or urine free light chain over 2 consecutive time points greater than 4 weeks apart)
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Ability to understand and the willingness to sign a written informed consent document
- Birth control is required with full barrier contraceptives or complete abstinence for the duration of time receiving therapy and for 6 months after completing the last drug taken
- The need for further treatment: this is defined as progression of clinical features (worsening anemia, renal function, bone disease, hypercalcemia, recurrent infections, and constitutional symptoms) OR biochemical progression (increasing M-spike in serum or urine, involved serum or urine free light chain over 2 consecutive time points greater than 4 weeks apart)
You may not qualify if…
- History of allergic reactions to compounds of similar chemical or biological composition to rapamycin or hydroxychloroquine
- Patients may not take any of the following medications while on study, but will be considered eligible if medication is discontinued at least 72 hours (hrs) prior to first dose of Rapamycin:
- Carbamazepine
- Rifabutin
- Rifampin
- Rifapentine
- St. John's wort
- Clarithromycin
- Cyclosporine
- Diltiazem
- Erythromycin
- Itraconazole
- Fluconazole
- Ketoconazole
- Telithromycin
- Verapamil
- Voriconazole
- Posaconazole
- Known macular degeneration or retinopathy (diabetic or otherwise), porphyria, or psoriasis (well-controlled psoriasis allowed provided under the care of a specialist who agrees to monitor the patient for exacerbations)
- Absolute neutrophil count (ANC) =< 1.0 x 10\^9/L
- Platelets =< 50 x 10\^9/L for any reason
- Serum creatinine >= 2.5 mg/dL
- Total or direct bilirubin >= 2.0 mg/dL
- Transaminases 2 x the upper limit of normal
- Fasting glucose >= 200 mg/dL
Where it is running
- OHSU Knight Cancer Institute — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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