NCT01349569 · REGISTRY CONDITION SEARCH

Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission

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: 2019-01-15

This research is being done to find out if the investigators can improve outcomes for multiple myeloma patients by giving a myeloma vaccine to patients who are already on lenalidomide (Revlimid) and in a near complete remission.

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

Response Conversion Rate

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outcome · POSTED

Time to Response

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outcome · POSTED

Effect on Clonogenic Myeloma Precursors

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outcome · POSTED

Grade 3-4 Toxicity

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outcome · POSTED

Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells

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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: * Myeloma eligibility criteria are the following: * sustained near complete remission (nCR) for 4 months defined as no measurable M-spike and a positive immunofixation * early biochemical relapse as manifest by going from a true CR (immunofixation negative) to a nCR (immunofixation positive) at any time * conversion from a nCR to the appearance of a monoclonal spike in the serum not greater than 0.3mg/dL * age 18 years and older * Eastern Cooperative Oncology Group performance scores 0-2 * History of measurable serum or urine M protein or free light chains * Life expectancy greater than 12 months * Corrected serum calcium \< 11 mg/dL, and no evidence of symptomatic hypercalcemia * Serum creatinine\< 2 * Absolute Neutrophil Count \>1000 * Platelet \>100,000 * Total bilirubin less than or equal to 1.5 x Upper limit of normal * Aspartate aminotransferase and Alanine transaminase less than or equal to 3 x Upper limit of normal * Negative pregnancy test if applicable * Ability to comprehend and have signed the informed consent. * Disease free of prior malignancies for \< 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. * All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. * Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods. * Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin). Exclusion Criteria: * Disease progression after stopping corticosteroids as defined as the appearance of an M-spike \>0.5g/dL * Patients with a known diagnosis of POEMS syndrome, plasma cell leukemia, non-secretory myeloma and amyloidosis. * HIV disease, active infection requiring treatment with antibiotics, anti-fungal or anti-viral agents within 2 weeks of enrollment would be excluded from the study. * Patients who have participated in any clinical trial, within four weeks prior to registration on this trial, which involved an investigational drug. * History of an active malignancy other than myeloma * Autoimmune disease requiring active treatment. * Known contra-indication to any component of Prevnar 13 including the diphtheria toxoid-containing vaccine. * History of latex allergy * History of an autologous stem cell transplant within the past 12 months or less * History of an allogeneic transplant
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Lenalidomide will be continued on the same dose as was being administered prior to the study. The allogeneic myeloma vaccine and Prevnar-13 vaccine will be given on four days over the course of the study.
intervention Names
Drug: Lenalidomide
Biological: Allogeneic Myeloma Vaccine
Biological: Prevnar-13
label
Myeloma Vaccine, Prevnar, & Lenalidomide
type
EXPERIMENTAL

interventions

arm Group Labels
Myeloma Vaccine, Prevnar, & Lenalidomide
description
Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).
name
Lenalidomide
other Names
Revlimid
type
DRUG
arm Group Labels
Myeloma Vaccine, Prevnar, & Lenalidomide
description
A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.
name
Allogeneic Myeloma Vaccine
type
BIOLOGICAL
arm Group Labels
Myeloma Vaccine, Prevnar, & Lenalidomide
description
Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.
name
Prevnar-13
other Names
Pneumococcal 13-Valent Conjugate Vaccine
type
BIOLOGICAL

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 19
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Number of participants who converted from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, \< 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with \< 5% plasma cells.
measure
Response Conversion Rate
time Frame
Up to 1 year

secondary Outcomes

description
Median time for conversion of response from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, \< 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with \< 5% plasma cells. as measured by immunofixation converting from positive to negative.
measure
Time to Response
time Frame
Up to 4 years
description
Measures of stem cell population and plasma cell population.
measure
Effect on Clonogenic Myeloma Precursors
time Frame
Baseline, Cycle 3 Day 14, Cycle 6 Day 14, and 1 year
description
Number of participants who experienced grade 3-4 toxicity as per CTCAE 4.0.
measure
Grade 3-4 Toxicity
time Frame
Up to 1 year
description
Immunity is measured by the percentage of CD3+/CSFSE-low/IFN-gamma+ cells. A positive result for a given participant is defined as greater than two standard deviations above that participant's baseline. The data are presented as three groups because the responses were analyzed separately, but all participants were part of the single study arm as represented by the remainder of the record. GVAX-specific immune response and Prevnar-specific immune response was assessed in the same patient by using GVAX and Prevnar-specific co-markers.
measure
Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells
time Frame
Baseline, Cycle 3 Day 14, end of study (up to 1 year)

Full study description

brief Summary: This research is being done to find out if the investigators can improve outcomes for multiple myeloma patients by giving a myeloma vaccine to patients who are already on lenalidomide (Revlimid) and in a near complete remission.
detailed Description: This is a single institution, single arm, Phase II study examining the clinical efficacy of an allogeneic GM-CSF secreting myeloma vaccine in combination with lenalidomide. Fifteen (15) patients enrolled in the study must have two disease measurements (including the last one) consistent with a near complete remission (M-spike negative with persistence of immunofixation) per criteria for response in a 6 month period. Patients will continue on the dose of lenalidomide they were on prior to being enrolled but will need to discontinue steroids for at least 4 weeks. Patients will receive 4 vaccinations on day 14(+/-3 days) of cycles 1, 2, 3 and 6 from enrollment that will include both the myeloma vaccine as well as Prevnar.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice