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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT04635735
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria prior to Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT):
* Willing and able to participate as a research subject and provide informed consent (Note: an LAR may sign the consent form on the partipant's behalf)
* Diagnosis of relapsed refractory multiple myeloma defined as more than 2 lines of prior therapy with at least a very good partial remission to most recent salvage therapy.
* Patients should have R-ISS stage II or III disease at diagnosis or high risk cytogenetics by IMWG criteria (t(4;14), del(17/17p), t(14;16), t(14;20), nonhyperdiploidy, and gain(1q)) at any time since diagnosis
Note:. A line of therapy is treatment between diagnosis and progression or between two progressions
* Eligible for CD34-selected HSCT according to MSKCC adult BMT guidelines.
* Have a 10/10 matched donor
* Age ≥ 21, \< 73 years.
* Karnofsky (adult) Performance Status ≥ 70%.
* Patients must have adequate organ function measured by:
1. Cardiac: LVEF at rest must be ≥ 50%
2. Hepatic:
* \< 3x ULN ALT
* \< 1.5 ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
3. Renal: serum creatinine \<1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl \> 40 ml/min (measured or calculated/estimated) with dose adjustment of Fludarabine for \<70ml/min
4. Pulmonary: DLCO \> 50% of predicted (corrected for hemoglobin).
Inclusion Criteria prior to Ipilimumab:
* Non progressive myeloma (partial response or better) as defined by International Myeloma Working Group (IMWG) criteria
* Engraftment of all cell lines without transfusion dependence, defined as:
* absolute neutrophil count \> 1.0K/mcL x 3 consecutive days
* platelets \> 50K/mcLx 7 consecutive days without platelet transfusion
* no platelet or RBC transfusions within the preceding 7 days
* ≥ 80% donor chimerism in the bone marrow
Exclusion Criteria:
Exclusion Criteria prior to Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT):
* Patients ineligible for therapy with ipilimumab, for example:.
1. Active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (\>10 mg daily of prednisone equivalents) or other immunosuppressive medications at enrollment. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
2. History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre Syndrome, Myasthenia Gravis).
* Female patients who are pregnant or breast-feeding.
* Patients with plasma cell leukemia at the time of diagnosis.
* Patients who have undergone prior allogeneic hematopoietic stem cell transplantation.
* Patients who have had a previous malignancy that is not in remission.
Exclusion Criteria prior to Ipilimumab:
* Active infection or treatment for infection (patients on Cytomegalovirus (CMV) therapy will be considered eligible; patients with CMV viremia by PCR or disease with end-organ involvement will not be eligible)
* Active GVHD of any grade or prior grade 3-4 GVHD
* Active immune suppression, defined as:
* active use of calcineurin inhibitors, mycophenolate mofetil, or other immunomodulators
* steroid dosing exceeding 10 mg/d prednisone or equivalent
* Receiving immunomodulatory agents (ex. thalidomide, lenalidomide, pomalidomide)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
73 Years
Study:
NCT04635735
Study Brief:
Protocol Section:
NCT04635735