Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplant… (NCT00948922) | Clinical Trial Compass
CompletedPhase 2
Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma
United States124 participantsStarted 2009-06-18
Plain-language summary
The purpose of this study is to evaluate the effectiveness of Bortezomib when added to standard chemotherapy medicine(s) for treatment of Multiple Myeloma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Multiple Myeloma Criteria(International Uniform Response Criteria for Multiple Myeloma)
* Patients with responsive disease after any line of induction therapy
* A complete response
* A very good partial response
* A partial response
* Patients greater than or equal to 18 years of age are eligible. There is upper age limit of 60 years for allogeneic transplants.
* Patients must have a histologically confirmed diagnosis.
* All patients should have a life expectancy of at least 12 weeks.
* Patients must have undergone a complete psychosocial evaluation and have been considered capable of compliance.
* Meet the following criteria for allogeneic hematopoietic cell transplant:
* Must have an identified donor match defined as: HLA-A, HLA-B, HLA- C, DRB1 8/8 allele matched sibling, family member, or unrelated donor. \[7/8 would go on separate mismatched trials\] and be \< 60 years of age.
* Calculated hematopoietic cell transplantation-specific comorbidity index (HCT-CI) \<3
Exclusion Criteria:
* Patients who do not achieve at least a partial response (PR) by the criteria mentioned above with induction therapy.
* Patient has a platelet count of \<30 x 10\^9/L within 14 days before enrollment.
* Patient has \>/= Grade 2 peripheral neuropathy within 30 days before enrollment.
* Patient has an absolute neutrophil count of \<1.0 x 10\^9/L within 30 days before enrollment.
* Myocardial infarction within 6 months prior to enrollment or has New York Hospital Associat…
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: End of 2 year, post transplant follow-up
Trial details
NCT IDNCT00948922
SponsorH. Lee Moffitt Cancer Center and Research Institute