Multiple MyelomaPhase 2NCT01858558

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

A Phase 2 study testing aMIL and No aMIL in people with Multiple Myeloma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Multiple Myeloma
What is being tested?: aMIL and No aMIL
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteUnited States
Study dates: Sep 2013to 19 Jun 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

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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.

Who cannot join

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;

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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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231

Other trials in United States

About this study

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

Conditions: Multiple Myeloma
Being tested: aMIL, No aMIL
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

aMILBiological
On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
No aMILDrug
On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.

Study groups in NCT01858558
Study group	Role	What they receive
aMIL Arm	Experimental	Patients receive activated Marrow Infiltrating Lymphocytes (aMIL) Receives: Biological: aMIL; Drug: No aMIL
No aMIL	Active comparator	Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL) Receives: Drug: No aMIL

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 120 days

Secondary outcomes (3)

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.
Measured: 60 days from aMILs harvest until day 60 after transplant
Overall Survival (OS)
OS assessed by number of participants alive at the end of follow up period.
Measured: 3 years
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.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201319 Jun 2019

First posted21 May 2013 (estimated)
Study startSep 2013
Primary completion19 Jun 2019
Study completion19 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01858558
Sponsor's protocol ID: J1343
Other IDs: NA_00084466
Status last verified: Jun 2020
First submitted: 14 May 2013
Last updated: 29 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01858558
Acronym / sponsor ID: J1343
Conditions: Multiple Myeloma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
Collaborators: The Leukemia and Lymphoma Society
Study start: Sep 2013 (actual)
Primary completion: 19 Jun 2019 (actual)
Study completion: 19 Jun 2019 (actual)
First posted: 21 May 2013 (estimated)
Results: Posted 29 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
aMIL Arm	Experimental	Biological: aMIL, Drug: No aMILPatients receive activated Marrow Infiltrating Lymphocytes (aMIL)
No aMIL	Active comparator	Drug: No aMILPatients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (17 listed)

Diagnosis of any of the following cancers:
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
aMILOn day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.	Biological	aMIL Arm
No aMILOn day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.	Drug	No aMIL, aMIL Arm

Primary outcome

Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
Time frame: 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.

3 secondary outcomes

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
Overall Survival (OS)
Time frame: 3 years
Progression-free Survival (PFS)
Time frame: 5 years

Results and safety

Results posted to the registry on 29 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
aMIL Arm	70	61
No aMIL	31	29

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

Time frame: 120 days. Count of participants. Unit: Participants

Measure	aMIL Arm n = 71
Total number who received aMILS	71
Feasible	46
Reason not feasible- failed harvest	1
Reason not feasible- disease progression	4
Reason not feasible- death	1
Reason not feasible- lost to follow-up	1
Reason not feasible- failed expansion	2
Reason not feasible- cell product contamination	2

Population analysed: 71 patients were evaluable in the feasibility set: 70 randomized to the aMILs Arm, plus one patient who was not randomized due to harvest failure.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 60 Days from aMILs harvest until Day 60 after transplant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
aMIL Arm	64 of 70 (91.4%)	11 of 70 (15.7%)	1 of 70
No aMIL	29 of 31 (93.5%)	0 of 31 (0%)	1 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philip Imus, M.D. principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aMIL and No aMIL in people with Multiple Myeloma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product (time frame: 120 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01858558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.