NCT01858558 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2020-06-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product

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outcome · POSTED

Toxicity as Determined by Total Number of Grade 3 or Higher Adverse Events

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Progression-free Survival (PFS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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).
healthy Volunteers: false
maximum Age: 80 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
intervention Names
Biological: aMIL
Drug: No aMIL
label
aMIL Arm
type
EXPERIMENTAL
description
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
intervention Names
Drug: No aMIL
label
No aMIL
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
aMIL Arm
description
On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
name
aMIL
type
BIOLOGICAL
arm Group Labels
No aMIL
aMIL Arm
description
On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
name
No aMIL
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 102
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
time Frame
120 days

secondary Outcomes

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

Full 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.

Source references

Source notices and limitations

Discovery and provenance

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source url
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Preserved source evidence · Not medical advice