Bortezomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Previously… (NCT00088855) | Clinical Trial Compass
CompletedPhase 2
Bortezomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma
United States55 participantsStarted 2004-06-15
Plain-language summary
This phase II trial studies the side effects and how well bortezomib and pegylated liposomal doxorubicin hydrochloride work in treating patients multiple myeloma that are experiencing symptoms and have not received prior treatment. Bortezomib and pegylated liposomal doxorubicin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a histologically confirmed diagnosis of symptomatic multiple myeloma with evaluable disease parameters
* A diagnosis of symptomatic multiple myeloma requires:
* A monoclonal serum and/or urine protein
* Clonal bone marrow plasmacytosis, or a histologically confirmed plasmacytoma
* Related organ or tissue impairment, consisting of:
* Hypercalcemia (serum calcium \> 0.25 mmol/l above the upper limit of normal, or \> 2.75 mmol/l \[i.e. \> 11.5 mg/dl\]) AND/OR
* Renal insufficiency (serum creatinine \> 173 mmol/l \[i.e., \> 2 mg/dL\]); (please note that serum creatinine may not be \>= 2.5 mg/dL) AND/OR
* Anemia (hemoglobin 2 g/dl below the lower limit of normal, or hemoglobin \< 10 g/dl) AND/OR
* Bony lesions (lytic bony lesions, or osteoporosis with compression fractures) AND/OR
* Other findings, such as symptomatic hyperviscosity, amyloidosis, or recurring bacterial infections (\> 2 episodes in 12 months)
* Patients may not have undergone any prior therapy, with the following exceptions:
* Prior plasmapheresis with plasma exchange (PLEX) for a hyperviscosity syndrome is allowed, providing the patient has no current evidence of hyperviscosity and has not required PLEX for at least one week prior to initiation of therapy
* Prior radiation therapy to areas of spinal cord compression by plasmacytomas, painful lesions due to bony involvement, or other myeloma-related indications, is allowed provided that radi…
What they're measuring
1
CR+nCR rate
Timeframe: After 18 weeks (6 courses of treatment)