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
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: aMIL Drug: No aMIL Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 2013
Actual Primary Completion Date : June 19, 2019
Actual Study Completion Date : June 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: aMIL Arm
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
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.

Active Comparator: No aMIL
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
Drug: No aMIL
On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.




Primary Outcome Measures :
  1. Feasibility of MILs to treat high risk Myeloma [ Time Frame: 7 years ]
    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.


Secondary Outcome Measures :
  1. Toxicity as determined by number of grade 3 or higher adverse events [ Time Frame: 7 years ]
    Proportion of subjects who experience adverse events grade 3 or higher that occur from MILs harvest through 60 days after transplant.

  2. Overall Survival (OS) [ Time Frame: 7 years ]
    Median OS time will be calculated from time of randomization until death due to any cause.

  3. Progression-free survival (PFS) [ Time Frame: 7 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
  • 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.
  • HTLV 1 or 2 positive;
  • Known hypersensitivity to Prevnar or any of its components;
  • Contraindication to phosphodiesterase-5 inhibitors (e.g. currently on nitrates).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858558


Locations
Layout table for location information
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
The Leukemia and Lymphoma Society
Investigators
Layout table for investigator information
Principal Investigator: Philip Imus, M.D. Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01858558    
Other Study ID Numbers: J1343
NA_00084466 ( Other Identifier: JHMIRB )
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: September 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases