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About
This phase I/II trial studies the side effects and best dose of bortezomib when given together with melphalan, and total-body irradiation before stem cell transplant and to see how well it works in treating patients with multiple myeloma. Giving chemotherapy and total-body irradiation before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The stem cells that were collected from the patient's blood or bone marrow are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and total-body irradiation.
Full description
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of bortezomib that can be added to high dose melphalan and low dose total body irradiation as part of conditioning chemotherapy for myeloma. (Phase I) II. To determine the efficacy of the bortezomib added to high dose melphalan and low dose total-body irradiation (TBI) in patients with myeloma undergoing stem cell transplantation, as defined by achievement of complete response (CR). (Phase II)
SECONDARY OBJECTIVES:
I. To examine the toxicities associated with addition of bortezomib to high dose melphalan and TBI in patients with multiple myeloma (MM).
II. To determine the progression free rate at 1 and 2 years.
TERTIARY OBJECTIVES:
I. To determine the proportion of patients achieving a minimal residual disease (MRD) negative status.
II. To assess the HevyLite assay prior to and during treatment.
OUTLINE: This is a phase I, dose-escalation study of bortezomib followed by a phase II study.
CONDITIONING REGIMEN: Patients receive bortezomib intravenously (IV) on days -5 and -2, TBI twice daily (BID) on days -5 and -2, and melphalan IV over 1 hour on days -4 and -3.
TRANSPLANT: Patients undergo autologous bone marrow or peripheral blood stem cell transplant on day 0.
After completion of study treatment, patients are followed up at 100 days and then every 90 days for up to 3 years.
Enrollment
Sex
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Volunteers
Inclusion criteria
Serum creatinine =< 2 mg/dL
Serum total bilirubin =< 1.5 X upper limit of normal (ULN)
Platelet count >= 30,000/μL
Hemoglobin >= 8.0 g/dL
Diagnosis of myeloma for which autologous stem cell transplant is being considered
Measurable disease of multiple myeloma at the time of baseline values for disease assessment as defined by at least one of the following:
NOTE:
Patient is considered for autologous stem cell transplantation with full dose melphalan (200 mg/m^2)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Recovered from non-hematological toxicity of previous chemotherapy (excludes grade 1 neurotoxicity)
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Ejection fraction >= 45%
Corrected pulmonary diffusion capacity of greater than or equal to 50%
Forced expiratory volume in one second (FEV1) >= 50%
Forced vital capacity (FVC) >= 50%
Negative pregnancy test performed =< 14 days prior to registration, for women of childbearing potential only
Willing to return to Mayo Clinic Rochester, for treatment and follow-up
Willing to provide blood and bone marrow samples for correlative research purposes
Exclusion criteria
Prior autologous or allogeneic bone marrow/peripheral blood stem cell transplant
More than two prior regimens for therapy of MM
Myocardial infarction within 6 months prior to enrollment, or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; NOTE: prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant
Seroreactivity for human immunodeficiency virus (HIV), human T-cell lymphotrophic virus (HTLV) I or II, hepatitis B virus (HBV), hepatitis C virus (HCV)
Other active malignancy < 2 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy
Any of the following:
Other co-morbidity, which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated lung disease or psychiatric illness
Concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Known allergies to any of the components of the investigational treatment regimen or required ancillary treatments
Patient has >= grade 2 peripheral neuropathy
Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
Primary purpose
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11 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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