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 March 2014 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: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Biological: aMIL
Drug: No aMIL
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: September 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aMIL Arm
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
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.
Active Comparator: No aMIL
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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);
  • Diagnosis of amyloidosis;
  • Previous hematopoietic stem cell transplantation;
  • 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 21 days of bone marrow collection involving 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;
  • History of an 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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858558

Contacts
Contact: Ivan Borrello, M.D. 410-955-4967 iborrell@jhmi.edu
Contact: Amy Sidorski, Nurse Practitioner akramer3@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Ivan Borrello, M.D.    410-955-4967      
Principal Investigator: Ivan Borrello, M.D.         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
The Leukemia and Lymphoma Society
Investigators
Principal Investigator: Ivan Borrello, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01858558     History of Changes
Other Study ID Numbers: J1343, NA_00084466
Study First Received: May 14, 2013
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant 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
Tadalafil
Lenalidomide
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014