Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
Multiple Myeloma
Conditions: official terms
Multiple Myeloma
Study Type
Study Phase
Phase 2
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: aMIL Type: Biological
Name: No aMIL Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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).
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Status: Recruiting
Contact: Ivan Borrello, M.D. - 410-955-4967
Start Date
September 2013
Completion Date
July 2018
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page