Tadalafil and Lenalidomide with or without Activated Marrow Infiltrating Lymphocytes in Treating Patients with High-Risk Multiple Myeloma Undergoing Stem Cell Transplant

Active:	No
Cancer Type:	Multiple Myeloma Plasma cell neoplasm	NCT ID:	NCT01858558
Trial Phases:	Phase II	Protocol IDs:	J1343 (primary) NCI-2013-01767 NA_00084466
Eligibility:	18 - 80 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Johns Hopkins University/Sidney Kimmel Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT01858558

Summary

This randomized phase II trial studies how well tadalafil and lenalidomide with or without activated marrow infiltrating lymphocytes work in treating patients with multiple myeloma undergoing stem cell transplant. Activated marrow infiltrating lymphocytes are blood and bone marrow cells that are stimulated to react to certain proteins and may help to target and kill cancer cells. Tadalafil may increase the possibility of trafficking activated marrow infiltrating lymphocytes to the cancer site. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving tadalafil and lenalidomide is more effective with or without activated marrow infiltrating lymphocytes in treating patients with multiple myeloma.

Objectives

PRIMARY OBJECTIVE:
I. Determine the progression free survival (PFS) of autologous stem cell transplant (ASCT) alone versus (vs) ASCT plus marrow infiltrating lymphocytes (MILs).

SECONDARY OBJECTIVES:
I. Evaluate toxicity.
II. Evaluate overall survival.
III. Determine immune responses.
IV. Anti-tumor immune responses.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive melphalan intravenously (IV) over 20-30 minutes on days -2 and -1 and undergo ASCT on day 0. Patients then receive tadalafil orally (PO) on days 2-11 and activated marrow infiltrating lymphocytes IV on days 3 and 4. Patients also receive lenalidomide PO beginning on day 60 and continue in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive melphalan IV over 20-30 minutes on days -2 and -1 and undergo ASCT on day 0. Patients then receive tadalafil PO on days 2-11. Patients also receive lenalidomide PO beginning on day 60 and continuing in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at days 28, 60, 180, and 360, and then every 3 months for 4 years.

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