Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858558
• Other study ID #: J1343
• Secondary ID: NA_00084466
• Status: Completed
• Phase: Phase 2
• Start date: September 2013
• Est. completion date: June 19, 2019

Study information

• Verified date: June 2020
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• aMIL
On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.

Drug:
• No aMIL
On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	The Leukemia and Lymphoma Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product	Feasibility is defined as the ability to harvest, expand, and infuse the MILs product within 120 days. After treating 60 patients with MILs, we will declare MILs not feasible if we can only harvest, expand, and deliver MILs to 40 or fewer patients.	120 days
Secondary	Toxicity as Determined by Total Number of Grade 3 or Higher Adverse Events	Total number of adverse events grade 3 or higher that occur from MILs harvest through 60 days after transplant.	60 days from aMILs harvest until day 60 after transplant
Secondary	Overall Survival (OS)	OS assessed by number of participants alive at the end of follow up period.	3 years
Secondary	Progression-free Survival (PFS)	Median PFS time equals the time of randomization (in months) until disease progression, death from any cause, or protocol deviation due to lenalidomide dosing (above 10mg), whichever occurs first.	5 years