Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT01163357
Eligibility Criteria:
Inclusion Criteria:
* Recipient must have signed a voluntary, informed consent in accordance with institutional and federal guidelines
* Recipients must have histopathologically confirmed diagnosis of multiple myeloma
* Age:
* Stratum I (TMI containing arm): 18-60 years of age
* Stratum II (non TMI arm): 18-70 years of age
* Patients with primary progressive disease on induction therapy with new targeted therapies
* Relapsed/refractory disease on new targeted therapies, i.e. thalidomide, lenalidomide, bortezomib, or other new novel agents such as carfilzomib, pomalidomide
* Patients with relapsed multiple myeloma following previous autologous stem cell transplant
* Plasma cell leukemia at diagnosis
* High-risk patients with presence of chromosome 17p deletion (\> 60%) in the bone marrow by fluorescence in situ hybridization (FISH); patients are not required to have prior autologous stem cell transplant
* Able to lie supine for approximately 60 minutes, the anticipated duration of each treatment session
* Performance status evaluated by Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Scales (KPS) patients must have a score of 0-II (ECOG) or \>= 70% (KPS)
* Cardiac ejection fraction \>= 50% by multiple gate acquisition (MUGA) scan and/or by echocardiogram
* Forced expiratory volume in one second (FEV1) \>= 50%
* Diffusing lung capacity for carbon monoxide (DLCO) \>= 50%
* Creatinine clearance or glomerular filtration rate (GFR) \>= 60 ml/min
* Serum bilirubin =\< 2.0 mg/dl
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) =\< 2.5 times the institutional upper limits of normal
* Pre-treatment tests must be performed within 30 days prior to enrollment
* No other medical and or psychosocial problems, which in the opinion of the primary physician or principal investigator would place the patient at unacceptable risk from this regimen
* Patients with no previous radiation or up to a maximum 2000 cGy to non thoracic-spine and rib bone lesions or \< 20% of bone marrow are eligible for TMI conditioning regimen
* Patients with previous history of irradiation at any dose to thoracic-spine, ribs or \>= 20% of bone marrow cannot undergo TMI and will be eligible for bortezomib, fludarabine, and melphalan regimen
Stratum II); patients can be enrolled on stratum II at their physician's discretion or if patients decline radiation therapy
DONOR: Any matched sibling donor (matched at HLA A, B, C by intermediate resolution typing and HLA-DRB1 by high resolution typing), or unmatched unrelated donor (matched at HLA A, B, C, DRB1 by high resolution typing) will be considered a suitable donor
Exclusion Criteria:
* Patients with peripheral neuropathy greater than grade II
* Major medical or psychiatric disorders that would seriously compromise patient tolerance of this regimen
* Human immunodeficiency virus (HIV) infection, active hepatitis B or C infection, or evidence of liver cirrhosis
* Active viral, bacterial or fungal infection unless adequately treated. For fungal infection, patient should have completed full course of antifungal therapy with resolution of infection.
* Patients with radiographic changes including pulmonary disease, including but not limited to: pulmonary nodules, infiltrates, pleural effusion are excluded unless cleared by pulmonary biopsy showing no evidence for pulmonary infection
* Patients with renal insufficiency or cr clearance \< 60 ml/min
DONOR: Donors will be excluded if for medical or psychological reasons they are unable to tolerate the procedure of peripheral stem cell donation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01163357
Study Brief:
Protocol Section:
NCT01163357