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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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