Clinical Trials /

Study of Ipilimumab After Stem Cell Transplantation in People With Relapsed/Refractory Multiple Myeloma

NCT04635735

Description:

This study will test the safety of ipilimumab to see what effects, if any, the drug has when used as maintenance therapy for people with relapsed/refractory multiple myeloma who have received chemotherapy and allogeneic hematopoietic stem cell transplant (AHCT). The investigators also want to find out whether giving ipilimumab after chemotherapy and AHCT is a better way to control the multiple myeloma than chemotherapy and AHCT alone.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Ipilimumab After Stem Cell Transplantation in People With Relapsed/Refractory Multiple Myeloma
  • Official Title: A Phase I/II Trial of Ipilimumab After CD34-Selected Allogeneic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: 20-329
  • NCT ID: NCT04635735

Conditions

  • Relapsed/Refractory Multiple Myeloma

Interventions

DrugSynonymsArms
IpilimumabIpilimumab After Stem Cell Transplantation

Purpose

This study will test the safety of ipilimumab to see what effects, if any, the drug has when used as maintenance therapy for people with relapsed/refractory multiple myeloma who have received chemotherapy and allogeneic hematopoietic stem cell transplant (AHCT). The investigators also want to find out whether giving ipilimumab after chemotherapy and AHCT is a better way to control the multiple myeloma than chemotherapy and AHCT alone.

Trial Arms

NameTypeDescriptionInterventions
Ipilimumab After Stem Cell TransplantationExperimentalThe patient will be admitted to a single room on the Adult Transplantation Service and allogeneic CD34-selected PBSC or marrow transplantation performed as per MSKCC adult BMT guidelines. Patients will be evaluated at approximately day 100 (±2 weeks) after allo-HSCT.
  • Ipilimumab

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)
      
Maximum Eligible Age:73 Years
Minimum Eligible Age:21 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase I: maximum tolerated dose of Ipilimumab
Time Frame:1 year
Safety Issue:
Description:A maximum of 12 patients will be accrued and DLTs will be assessed in these patients. If any DLT is observed in more than one of the six patient cohort, a lower dose of ipilimumab will be evaluated in a new six patient cohort.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Ipilimumab
  • Stem Cell Transplantation
  • 20-329

Last Updated

November 19, 2020