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 @ 2:25 PM
Ignite Modification Date:
2025-12-24 @ 2:25 PM
NCT ID:
NCT00995059
Eligibility Criteria:
Inclusion Criteria:
* ECOG performance status (PS) 0, 1, or 2
* Diagnosis of symptomatic multiple myeloma
* High risk myeloma as defined by progressive disease =\< 12 months after high dose chemotherapy and autologous HSC transplant or presences of poor prognostic features such as deletion of chromosome 13 or hypodiploidy by standard cytogenetics, or t(4; 14) by fluorescence in situ hybridization (FISH), or t(14;16) by FISH, or 17p- by FISH, or plasma cell labeling index \>= 3%
* Availability of a HLA fully-matched or 1 mismatch related donor by low-resolution HLA typing for the loci A, B, C, DRB1 and DQB1 or HLA fully-matched unrelated donor by high-resolution typing for loci A, B, C and DRB1 and at least low-resolution for loci DQB1
* Recovery from toxicity of previous chemotherapy (excludes grade 1 neurotoxicity and hematological toxicity)
* Physically and psychologically capable of undergoing bone marrow or PBSC transplant
* 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
* Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the during of the study
* Male subject agrees to use an acceptable method for contraception for the duration of the study
Exclusion Criteria:
* Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* NOTE: Prior to study entry, and ECG abnormality at screening has to be documented by the investigator as not medically relevant
* Significant cardiac dysfunction defined as left ventricle ejection fraction \< 40% or presence of symptomatic coronary artery disease
* Significant pulmonary disease defined as FEV \< 50% or CLCO \< 50% of the predicted values
* Pre existing peripheral neuropathy grade \> 1
* Significant renal dysfunction defined as estimated creatinine clearance \< 50 ml/min
* Significant liver dysfunction defined as total bilirubin \>= 2 x upper limit of normal (ULN) or AST, ALT \>= 3 x ULN
* Seroreactive for HIV, HTLV I or II, HBV, HCV
* Presence of uncontrolled bacterial, viral, or fungal infection
* Known allergy to any of the component of the investigational treatment regimen or required ancillary treatments
* Considered unable to tolerate the included doses of total body irradiation due to previous treatment with radiation
* Female subject is pregnant or breast-feeding
* Other active concurrent malignancy
* Prior allogeneic bone marrow/peripheral blood stem cell transplant
* Received other investigational drugs =\< 14 days prior to enrollment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00995059
Study Brief:
Protocol Section:
NCT00995059