Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Biological: pneumococcal polyvalent vaccine Drug: lenalidomide	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: multiple myeloma

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Lenalidomide Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

Genetic and Rare Diseases Information Center resources: Multiple Myeloma Anaplastic Plasmacytoma

U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:

6B Antibody Response to Prevnar Vaccine in Peripheral Blood [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: basline and 8 weeks after second vaccination ]
Serum IgG levels against the PVC serotype were measured by ELISA


Enrollment:	22
Study Start Date:	January 2007
Study Completion Date:	September 2010
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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).	Biological: pneumococcal polyvalent vaccine Given intramuscularly Drug: lenalidomide Given orally
Experimental: 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).	Biological: pneumococcal polyvalent vaccine Given intramuscularly Drug: lenalidomide Given orally

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445484

Locations


United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators


Study Chair:	Ivan Borrello, MD	Sidney Kimmel Comprehensive Cancer Center

More Information

Publications:

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.


Responsible Party:	Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00445484 History of Changes
Other Study ID Numbers:	J06102 CDR0000532944 P30CA006973 ( U.S. NIH Grant/Contract ) JHOC-J06102 JHOC-NA_00006008 CELGENE-CC-5013
Study First Received:	March 7, 2007
Results First Received:	June 26, 2015
Last Updated:	August 5, 2015

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:


stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma

Additional relevant MeSH terms:


Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases	Vaccines Lenalidomide Thalidomide Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 21, 2017