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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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


Inclusion Criteria:



- 18 years old or greater;

- 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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Description:

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).

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Ivan Borrello, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Food and Drug Administration

Study ID:

J1343

NCT ID:

NCT01858558

Start Date:

June 2013

Completion Date:

July 2018

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410