Back to resultsTadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aMIL
No aMIL
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
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).
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
aMIL Arm
No aMIL
Arm Description
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Overall Survival (OS)
OS assessed by number of participants alive at the end of follow up period.
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.
Full Information
NCT ID
NCT01858558
First Posted
May 14, 2013
Last Updated
June 11, 2020
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
The Leukemia and Lymphoma Society
1. Study Identification
Unique Protocol Identification Number
NCT01858558
Brief Title
Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
June 19, 2019 (Actual)
Study Completion Date
June 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
The Leukemia and Lymphoma Society
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aMIL Arm
Arm Type
Experimental
Arm Description
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
Arm Title
No aMIL
Arm Type
Active Comparator
Arm Description
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
Intervention Type
Biological
Intervention Name(s)
aMIL
Intervention Description
On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
Intervention Type
Drug
Intervention Name(s)
No aMIL
Intervention Description
On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
Primary Outcome Measure Information:
Title
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
Description
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.
Time Frame
120 days
Secondary Outcome Measure Information:
Title
Toxicity as Determined by Total Number of Grade 3 or Higher Adverse Events
Description
Total number of adverse events grade 3 or higher that occur from MILs harvest through 60 days after transplant.
Time Frame
60 days from aMILs harvest until day 60 after transplant
Title
Overall Survival (OS)
Description
OS assessed by number of participants alive at the end of follow up period.
Time Frame
3 years
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Imus, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
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