Phase 2
Completed N=16
Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission
Source: ClinicalTrials.gov NCT01349569 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Jan 2019
Primary outcomePrimary: Response Conversion Rate — 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Conversion Rate |
8 | — |
| SECONDARY Time to Response |
11.7 | — |
| SECONDARY Effect on Clonogenic Myeloma Precursors |
— | — |
| SECONDARY Grade 3-4 Toxicity |
— | — |
| SECONDARY Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells |
1.2; 0.36; 0; 7.3; 13.3; 4.54 | — |
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 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 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
Data sourced from ClinicalTrials.gov (NCT01349569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.