Clinical trial NCT01858558: Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: The Leukemia and Lymphoma Society
First posted: 2013-05-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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;
* 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).

Primary outcomes:
measure: Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
timeFrame: 120 days
Secondary outcomes:
measure: Toxicity as Determined by Total Number of Grade 3 or Higher Adverse Events
timeFrame: 60 days from aMILs harvest until day 60 after transplant
measure: Overall Survival (OS)
timeFrame: 3 years
measure: Progression-free Survival (PFS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Philip Imus, M.D.
role: PRINCIPAL_INVESTIGATOR
References: