Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01858558
Recruitment Status : Completed
First Posted : May 21, 2013
Results First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE May 14, 2013
First Posted Date  ICMJE May 21, 2013
Results First Submitted Date  ICMJE June 11, 2020
Results First Posted Date  ICMJE June 29, 2020
Last Update Posted Date June 29, 2020
Actual Study Start Date  ICMJE September 2013
Actual Primary Completion Date June 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product [ Time Frame: 120 days ]
Feasibility is defined as the ability to harvest, expand, and infuse the MILs product within 120 days. After treating 60 patients with MILs, we will declare MILs not feasible if we can only harvest, expand, and deliver MILs to 40 or fewer patients.
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
Progression free survival [ Time Frame: 2 years ]
Determine the efficacy of Activated Marrow Infiltrating Lymphocytes (aMILS) in prolonging progression free survival (PFS) in patients with high risk multiple myeloma followed by Autologous Stem Cell Transplantation (ASCT).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
  • Toxicity as Determined by Total Number of Grade 3 or Higher Adverse Events [ Time Frame: 60 days from aMILs harvest until day 60 after transplant ]
    Total number of adverse events grade 3 or higher that occur from MILs harvest through 60 days after transplant.
  • Overall Survival (OS) [ Time Frame: 3 years ]
    OS assessed by number of participants alive at the end of follow up period.
  • Progression-free Survival (PFS) [ Time Frame: 5 years ]
    Median PFS time equals the time of randomization (in months) until disease progression, death from any cause, or protocol deviation due to lenalidomide dosing (above 10mg), whichever occurs first.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
  • Toxicity [ Time Frame: 1 year ]
    Adverse events related to the infusion of aMILs will be collected.
  • Overall Survival [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
Official Title  ICMJE Randomized Phase II Study of Autologous Stem Cell Transplantation With Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
Brief Summary This research is being done to find out if altering the immune system by giving activated marrow infiltrating lymphocytes (MILs) can improve outcomes for multiple myeloma patients who receive a standard autologous stem cell transplant.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Biological: aMIL
    On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
  • Drug: No aMIL
    On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
Study Arms  ICMJE
  • Experimental: aMIL Arm
    Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
    Interventions:
    • Biological: aMIL
    • Drug: No aMIL
  • Active Comparator: No aMIL
    Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
    Intervention: Drug: No aMIL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2020)
102
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2013)
90
Actual Study Completion Date  ICMJE June 19, 2019
Actual Primary Completion Date June 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 - 80 years old;
  • Patients with active myeloma requiring systemic treatment;
  • Newly diagnosed patients. Relapsed myeloma patients that have not previously had a transplant;
  • Meeting criteria for high-risk disease;
  • Measurable serum and/or urine M-protein from prior to induction therapy documented and available. A positive serum free lite assay is acceptable;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 (see Appendix C).
  • Meet all institutional requirements for autologous stem cell transplantation;
  • The patient must be able to comprehend and have signed the informed consent;
  • Patients must have had > than PR after last therapy.

Exclusion Criteria:

  • Diagnosis of any of the following cancers:

    • POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein] and skin changes);
    • Non-secretory myeloma (no measurable protein on Serum Free Lite Assay);
    • Plasma cell leukemia;
  • Diagnosis of amyloidosis;
  • Failed to achieve at least a partial response (PR) to latest therapy;
  • Previous hematopoietic stem cell transplantation;Patients can have had prior relapsed disease as long as they have never been previously transplanted;
  • Known history of HIV infection;
  • Use of corticosteroids (glucocorticoids) within 21 days of bone marrow collection;
  • Use of any myeloma-specific therapy within 21 days of bone marrow collection;
  • Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of registration;
  • Participation in any clinical trial within 28 days of registration on this trial, which involved an investigational drug or device;
  • History of malignancy other than multiple myeloma within five years of registration, except adequately treated basal or squamous cell skin cancer;
  • Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring active systemic treatment. Hypothyroidism without evidence of Grave's disease or Hashimoto's thyroiditis is permitted.
  • Human T-lymphotropic virus (HTLV) 1 or 2 positive;
  • Known hypersensitivity to Prevnar or any of its components;
  • Contraindication to phosphodiesterase-5 inhibitors (e.g. currently on nitrates).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01858558
Other Study ID Numbers  ICMJE J1343
NA_00084466 ( Other Identifier: JHMIRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE The Leukemia and Lymphoma Society
Investigators  ICMJE
Principal Investigator: Philip Imus, M.D. Johns Hopkins University
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP