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

NCT01858558 | Completed Phase 2 Results DMC

• 2 other identifiers: J1343NA_00084466
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  120 days

Secondary Outcomes (3)

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

  60 days from aMILs harvest until day 60 after transplant

• Overall Survival (OS)

  3 years

• Progression-free Survival (PFS)

  5 years

Study Arms (2)

aMIL Arm

EXPERIMENTAL

Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)

Biological: aMIL; Drug: No aMIL

No aMIL

ACTIVE COMPARATOR

Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)

Drug: No aMIL

Interventions

aMIL BIOLOGICAL

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

aMIL Arm

No aMIL DRUG

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

No aMIL; aMIL Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Philip Imus, MD
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

pimus1@jhmi.edu

410-955-8873

Study Officials

• Philip Imus, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 21, 2013
• Study Start: September 1, 2013
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: June 29, 2020
• Results First Posted: June 29, 2020

Record last verified: 2020-06

Locations

US (1)