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Randomized Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic GM-CSF-based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Randomized Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic GM-CSF-based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma


Inclusion Criteria:



- Durie-Salmon Stage II or III multiple myeloma

- Newly diagnosed either prior to receiving treatment or having completed induction
therapy

- Relapsed myeloma not previously transplanted within the past 5 years

- Measurable serum and/or urine M-protein from prior to induction therapy documented
and available. A positive serum free lite assay is acceptable

- Age greater than 18 years old

- ECOG performance status of 0 - 2

- Meet all institutional requirements for autologous stem cell transplantation

- The patient must be able to comprehend and have signed the informed consent

Exclusion Criteria:

- Diagnosis of any of the following plasma cell disorders: 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

- Amyloidosis

- Use of corticosteroids (glucocorticoids) within 21 days of pre-transplant vaccine or
bone marrow collection

- Use of any myeloma-specific therapy other than lenalidomide within 21 days of
pre-transplant vaccine

- In a complete remission at the time of bone marrow collection

- Infection requiring treatment with antibiotics, antifungal, or antiviral agents
within seven days of vaccination or bone marrow collection

- Participation in any clinical trial, within four weeks prior to vaccination or bone
marrow collection on this trial, which involved an investigational drug or device

- History of malignancy other than multiple myeloma within five years of vaccination or
bone marrow collection, except adequately treated basal or squamous cell skin cancer

- Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic
lupus erythematosis) requiring systemic treatment. Hypothyroidism without evidence of
Grave's Disease or Hashimoto's thyroiditis is permitted

- Evidence of spinal cord compression at time of transplant

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate clinical efficacy of activated marrow infiltrating lymphocytes (aMILs) administered alone or in combination with allogeneic myeloma cell vaccine combined with GM-CSF producing bystander cell in patients undergoing an ASCT for multiple myeloma.

Outcome Description:

2.1.1 Evaluate Response Rates utilizing the Blade' criteria Complete Response (CR) rate Near Complete Response (nCR) rate Very Good Partial Response (VGPR) rate Partial Response (PR) rate Minimal Response (MR) rate Overall response rate (CR, VGPR, PR)

Outcome Time Frame:

Days 60, 180, and 360

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

J0997

NCT ID:

NCT01045460

Start Date:

December 2009

Completion Date:

December 2015

Related Keywords:

  • Multiple Myeloma
  • Patients with active myeloma (Stage II/III) that have completed induction therapy and are eligible for an autologous stem cell transplant
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410