Back to results

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

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

pneumococcal polyvalent vaccine

lenalidomide

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Diagnosis of multiple myeloma (MM) meeting all of the following criteria:
- Relapsed or refractory disease
- Previously received ≥ 2 courses of antimyeloma treatment
Measurable levels of myeloma paraprotein in serum (> 0.5 g/dL) or urine (> 0.2 g/24-hour urine collection) OR serum-free light-chain disease

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Absolute neutrophil count ≥ 1,000/mm^3
Platelet count ≥ 75,000/mm^3
Creatinine ≤ 2.5 mg/dL
Bilirubin ≤ 2.0 mg/dL
AST and ALT ≤ 3 times upper limit of normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 methods of highly effective contraception ≥ 4 weeks before, during, and for 4 weeks after completion of study therapy
No other malignancy within the past 5 years except treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study treatment or put patient at unacceptable risk
No known hypersensitivity to thalidomide or lenalidomide
- No development of erythema nodosum in the presence of a reaction characterized by a desquamating rash while taking thalidomide or similar drugs
No known hypersensitivity to any component of the pneumococcal polyvalent vaccine, including diphtheria toxin or CRM 197
No known HIV positivity
No infectious hepatitis type A, B, or C

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No more than 3 prior treatment regimens for MM
More than 6 months since prior lenalidomide
More than 28 days since prior experimental drug or therapy
More than 1 month since prior systemic antimyeloma therapy
More than 1 month since prior and no concurrent systemic corticosteroids
No other concurrent anticancer agents or treatments or investigational agents
No concurrent thalidomide
No concurrent radiotherapy
No other concurrent immune therapy or immunomodulatory agents

Sites / Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

6B Antibody Response to Prevnar Vaccine in Peripheral Blood

Serum IgG levels against the PVC serotype were measured by ELISA

14F Antibody Response to Prevnar Vaccine in Peripheral Blood

Serum IgG levels against the PVC serotype were measured by ELISA

19F Antibody Response to Prevnar Vaccine in Peripheral Blood

Serum IgG levels against the PVC serotype were measured by ELISA

23F Antibody Response to Prevnar Vaccine in Peripheral Blood

Serum IgG levels against the PVC serotype were measured by ELISA

Secondary Outcome Measures

Full Information

NCT ID

NCT00445484

First Posted

March 7, 2007

Last Updated

August 5, 2015

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00445484

Brief Title

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

Official Title

Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

pneumococcal polyvalent vaccine

Intervention Description

Given intramuscularly

Intervention Type

Drug

Intervention Name(s)

lenalidomide

Intervention Description

Given orally

Primary Outcome Measure Information:

Title

6B Antibody Response to Prevnar Vaccine in Peripheral Blood

Description

Serum IgG levels against the PVC serotype were measured by ELISA

Time Frame

basline and 8 weeks after second vaccination

Title

14F Antibody Response to Prevnar Vaccine in Peripheral Blood

Description

Serum IgG levels against the PVC serotype were measured by ELISA

Time Frame

basline and 8 weeks after second vaccination

Title

19F Antibody Response to Prevnar Vaccine in Peripheral Blood

Description

Serum IgG levels against the PVC serotype were measured by ELISA

Time Frame

basline and 8 weeks after second vaccination

Title

23F Antibody Response to Prevnar Vaccine in Peripheral Blood

Description

Serum IgG levels against the PVC serotype were measured by ELISA

Time Frame

basline and 8 weeks after second vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma (MM) meeting all of the following criteria: Relapsed or refractory disease Previously received ≥ 2 courses of antimyeloma treatment Measurable levels of myeloma paraprotein in serum (> 0.5 g/dL) or urine (> 0.2 g/24-hour urine collection) OR serum-free light-chain disease PATIENT CHARACTERISTICS: ECOG performance status 0-2 Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 75,000/mm^3 Creatinine ≤ 2.5 mg/dL Bilirubin ≤ 2.0 mg/dL AST and ALT ≤ 3 times upper limit of normal Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 methods of highly effective contraception ≥ 4 weeks before, during, and for 4 weeks after completion of study therapy No other malignancy within the past 5 years except treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study treatment or put patient at unacceptable risk No known hypersensitivity to thalidomide or lenalidomide No development of erythema nodosum in the presence of a reaction characterized by a desquamating rash while taking thalidomide or similar drugs No known hypersensitivity to any component of the pneumococcal polyvalent vaccine, including diphtheria toxin or CRM 197 No known HIV positivity No infectious hepatitis type A, B, or C PRIOR CONCURRENT THERAPY: See Disease Characteristics No more than 3 prior treatment regimens for MM More than 6 months since prior lenalidomide More than 28 days since prior experimental drug or therapy More than 1 month since prior systemic antimyeloma therapy More than 1 month since prior and no concurrent systemic corticosteroids No other concurrent anticancer agents or treatments or investigational agents No concurrent thalidomide No concurrent radiotherapy No other concurrent immune therapy or immunomodulatory agents

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ivan Borrello, MD

Organizational Affiliation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Official's Role

Study Chair

Facility Information:

Facility Name

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231-2410

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22241792

Citation

Noonan K, Rudraraju L, Ferguson A, Emerling A, Pasetti MF, Huff CA, Borrello I. Lenalidomide-induced immunomodulation in multiple myeloma: impact on vaccines and antitumor responses. Clin Cancer Res. 2012 Mar 1;18(5):1426-34. doi: 10.1158/1078-0432.CCR-11-1221. Epub 2012 Jan 12.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs