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

NCT ID: NCT01858558

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2019-06-19

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aMIL Arm

Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)

Group Type: EXPERIMENTAL

aMIL

Intervention Type: BIOLOGICAL

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

No aMIL

Intervention Type: DRUG

On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.

No aMIL

Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)

Group Type: ACTIVE_COMPARATOR

No aMIL

Intervention Type: DRUG

On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.

Interventions

aMIL

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

Intervention Type: BIOLOGICAL

No aMIL

On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leukemia and Lymphoma Society

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Imus, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NA_00084466

Identifier Type: OTHER

Identifier Source: secondary_id

J1343

Identifier Type: -

Identifier Source: org_study_id