Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01858558
First received: May 14, 2013
Last updated: October 14, 2016
Last verified: October 2016

May 14, 2013
October 14, 2016
September 2013
December 2017   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Determine the efficacy of Activated Marrow Infiltrating Lymphocytes (MILs) in prolonging progression free survival (PFS) in patients with high risk multiple myeloma followed by Autologous Stem Cell Transplantation (ASCT).
Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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).
Complete list of historical versions of study NCT01858558 on ClinicalTrials.gov Archive Site
  • Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Adverse events related to the infusion of activated MILs will be collected.
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Adverse events related to the infusion of aMILs will be collected.
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
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
This research is being done to find out if altering the immune system by giving Prevnar vaccine, Tadalafil, and activated marrow infiltrating lymphocytes (MILs) can improve outcomes for multiple myeloma patients who receive a standard autologous stem cell transplant.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Biological: aMIL
    Patients will receive Prevnar vaccine followed by aMIL harvest. On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
  • Drug: No aMIL
    Patients will receive Prevnar vaccine followed by aMIL harvest. On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
July 2018
December 2017   (final data collection date for primary outcome measure)

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).
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact: Ivan Borrello, M.D. 410-955-4967 iborrell@jhmi.edu
Contact: Amy Sidorski, Nurse Practitioner akramer3@jhmi.edu
United States
 
NCT01858558
J1343, NA_00084466
Yes
Not Provided
Not Provided
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
The Leukemia and Lymphoma Society
Principal Investigator: Ivan Borrello, M.D. Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
October 2016

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