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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Biological: aMIL; Drug: No aMIL

• Registration Number: NCT01858558
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-21
• Study Start: 2013-09
• Primary Completion: 2019-06-19
• Study Completion: 2019-06-19
• Status Verified: 2020-06
• Results First Submitted: 2020-06-11
• Results First Submitted QC: 2020-06-11
• Last Update Submitted: 2020-06-11
• Results First Posted: 2020-06-29
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aMIL Arm	aMIL	Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
No aMIL	No aMIL	Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
aMIL Arm	No aMIL	Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)

Primary Outcome Measures

Name	Time	Method
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product	120 days	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	5 years	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.
Toxicity as Determined by Total Number of Grade 3 or Higher Adverse Events	60 days from aMILs harvest until day 60 after transplant	Total number of adverse events grade 3 or higher that occur from MILs harvest through 60 days after transplant.
Overall Survival (OS)	3 years	OS assessed by number of participants alive at the end of follow up period.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States