Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 2

Completed

• Conditions: Multiple Myeloma and Plasma Cell Neoplasm
• Interventions: Biological: pneumococcal polyvalent vaccine; Drug: lenalidomide

• Registration Number: NCT00445484
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

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 and/or 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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-09
• Primary Completion: 2009-04
• Study Completion: 2010-09
• Results First Submitted: 2015-06-26
• Results First Submitted QC: 2015-06-26
• Results First Posted: 2015-07-24
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	pneumococcal polyvalent vaccine	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	pneumococcal polyvalent vaccine	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).
Group 1	lenalidomide	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	lenalidomide	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).

Primary Outcome Measures

Name	Time	Method
6B Antibody Response to Prevnar Vaccine in Peripheral Blood	basline and 8 weeks after second vaccination	Serum IgG levels against the PVC serotype were measured by ELISA
23F Antibody Response to Prevnar Vaccine in Peripheral Blood	basline and 8 weeks after second vaccination	Serum IgG levels against the PVC serotype were measured by ELISA
14F Antibody Response to Prevnar Vaccine in Peripheral Blood	basline and 8 weeks after second vaccination	Serum IgG levels against the PVC serotype were measured by ELISA
19F Antibody Response to Prevnar Vaccine in Peripheral Blood	basline and 8 weeks after second vaccination	Serum IgG levels against the PVC serotype were measured by ELISA

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States