Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445484
Status:
COMPLETED
Last Update Posted:
2015-08-24
First Post:
2007-03-07
Brief Title:
Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Biological therapies such as lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing Vaccines may help the body build an effective immune response to kill cancer cells Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells
PURPOSE This phase II trial is studying how well giving lenalidomide together with vaccine therapy works in treating patients with relapsed or refractory multiple myeloma
PURPOSE This phase II trial is studying how well giving lenalidomide together with vaccine therapy works in treating patients with relapsed or refractory multiple myeloma
Detailed Description:
OBJECTIVES
Primary
Determine whether lenalidomide can augment the efficacy of pneumococcal polyvalent vaccine as it correlates with lenalidomide-induced antitumor efficacy in patients with relapsed or refractory multiple myeloma
Secondary
Determine the antibody responses to pneumococcal serotypes in patients treated with this regimen
Determine T-cell responses to the carrier protein CRM 197 in patients treated with this regimen
Determine the ability of lenalidomide to augment in vivo immune responsiveness as measured by cutaneous delayed-type hypersensitivity DTH reactions to Candida and tetanus in these patients
Determine the ability of lenalidomide to prime andor boost systemic vaccine responses in both peripheral blood lymphocytes and marrow lymphocytes in these patients
OUTLINE Patients are assigned to 1 of 2 treatment groups
Group 1 Patients receive oral lenalidomide on days 1-21 Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity Patients receive pneumococcal polyvalent vaccine intramuscularly IM 14 days prior to beginning lenalidomide and again in approximately 2 months after the first dose of the vaccine
Group 2 Patients receive lenalidomide as in group 1 Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months after the first dose of the vaccine
After completion of study treatment patients are followed at 30 days
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Determine whether lenalidomide can augment the efficacy of pneumococcal polyvalent vaccine as it correlates with lenalidomide-induced antitumor efficacy in patients with relapsed or refractory multiple myeloma
Secondary
Determine the antibody responses to pneumococcal serotypes in patients treated with this regimen
Determine T-cell responses to the carrier protein CRM 197 in patients treated with this regimen
Determine the ability of lenalidomide to augment in vivo immune responsiveness as measured by cutaneous delayed-type hypersensitivity DTH reactions to Candida and tetanus in these patients
Determine the ability of lenalidomide to prime andor boost systemic vaccine responses in both peripheral blood lymphocytes and marrow lymphocytes in these patients
OUTLINE Patients are assigned to 1 of 2 treatment groups
Group 1 Patients receive oral lenalidomide on days 1-21 Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity Patients receive pneumococcal polyvalent vaccine intramuscularly IM 14 days prior to beginning lenalidomide and again in approximately 2 months after the first dose of the vaccine
Group 2 Patients receive lenalidomide as in group 1 Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months after the first dose of the vaccine
After completion of study treatment patients are followed at 30 days
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CELGENE-CC-5013 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| JHOC-J06102 | None | None | None |
| JHOC-NA_00006008 | None | None | None |