Busulfan, Melphalan, and Bortezomib Before First-Line Stem Cell Transplant in Treating Patients W… (NCT01605032) | Clinical Trial Compass
CompletedPhase 2
Busulfan, Melphalan, and Bortezomib Before First-Line Stem Cell Transplant in Treating Patients With Multiple Myeloma
United States19 participantsStarted 2012-02
Plain-language summary
This phase II trial studies how well busulfan, melphalan, and bortezomib before first-line stem cell transplant works in treating patients with multiple myeloma. Giving chemotherapy before a peripheral blood stem cell transplant may stop the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
Who can participate
Age range18 Years – 72 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed multiple myeloma
* Measurable disease must be present as defined by protein criteria (quantifiable M-component in serum, urine or serum free light chains) in order to evaluate response as per IMWG; non-secretory patients are eligible provided the patient has \> 20% plasmacytosis OR multiple (\> 3) focal plasmacytomas or focal lesions on magnetic resonance imaging (MRI)
* Patients must have received induction chemotherapy for myeloma, but not more than 12 months of prior chemotherapy for this disease, and must be eligible for the first planned autologous transplant
* A minimum stem cell dose of 2.0 x 10\^6 cluster of differentiation 34-positive (CD34+) cells/kg has been collected
* Life expectancy of greater than 12 months
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Leukocytes \>= 3,000/mcL (unless myeloma related)
* Absolute neutrophil count \>= 1,500/mcL (unless myeloma related)
* Platelets \>= 50,000/mcL (unless myeloma related)
* Total bilirubin =\< 2 x institutional upper limit of normal unless 2nd to Gilbert's disease
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional upper limit of normal
* Creatinine =\< 1.5 x institutional upper limit of normal OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients …
What they're measuring
1
Rate of Complete Response as Determined by the IMWG Criteria