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This study involves receiving blinatumomab after high-dose melphalan and ASCT for multiple myeloma. The main purpose of this study is to: - To determine whether blinatumomab is safe and feasible to administer after ASCT in patients with advanced multiple myeloma. - To assess how long multiple myeloma remains under control when blinatumomab is administered after second ASCT.
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Inclusion criteria
Subjects must have undergone a prior ASCT for multiple myeloma and have progressed within 365 days of stem cell infusion. Progression is defined according to IMWG criteria49.
Prior ASCT must have utilized melphalan conditioning at a dose of 200 mg/m2.
Patients who underwent syngeneic transplant (i.e., transplant from an identical twin donor) rather than autologous transplant are eligible if syngeneic stem cells are available for use in the salvage transplant and syngeneic transplant will be considered equivalent to ASCT for the purposes of these inclusion/exclusion criteria.
Patients in whom first progression is identified between days 366 and 450 (inclusive) after ASCT will be eligible if progression is identified on their first evaluation for progression in this window and if they had not been evaluated between days 270 and 365 for progression. This clause is to account for practice patterns in which patients otherwise doing well are monitored infrequently (every 3-6 months) for relapse after they recover from their first ASCT. This will allow infrequently monitored patients to be included if progression is identified on their "12 month follow-up evaluation" if this appointment happens to be scheduled just outside the 365-day post-ASCT window.
There is no requirement that patients must enroll within 365 days of prior ASCT, and patients may be treated with other agents, including experimental agents, following relapse/progression after prior ASCT before enrollment on this study.
Subjects must have signed written, informed consent.
Subjects must be ≥ 18 and ≤ 70 years of age.
Subjects must have adequate vital organ function to undertake ASCT, defined as the following:
Subjects must have measurable disease, as defined in the IMWG response criteria49, on study entry.
Subjects must have an ECOG performance status of 0-2 unless a higher performance status is due solely to bone pain.
Subjects must have stored in usable condition for second ASCT, as judged by the principal investigator, ≥3x106 CD34+ cells per kg of body weight (either autologous or syngeneic) stored in at least two bags such that after administration of the minimum dose of 2 x 106 CD34+ cells/kg required on this protocol that a separate aliquot of at least 1 x 106 CD34+ cells/kg remains for rescue infusion in the event of graft failure.
Subjects must agree not to attempt to become pregnant or impregnate others (e.g., through sexual intercourse or sperm donation) between enrollment and completion of blinatumomab therapy. Sexually active subjects with reproductive potential must agree during the study to utilize a reliable method of contraception, which may include condoms (male or female), diaphragm or cervical cap with spermicide, intrauterine device, or hormonal contraceptive. Acceptable documentation of the absence of reproductive potential may consist of any one of the following: (1) physician report/letter, (2) operative report or other source documentation of surgical sterilization, (3) laboratory report of azospermia (required to document successful vasectomy), (4) follicle stimulating hormone measurement elevated in the menopausal range.
Due to the potential for neurological events, including seizures, while receiving blinatumomab, subjects must be willing and able to refrain from driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery during the periods of blinatumomab infusion.
Exclusion criteria
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6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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