Infections

All Conditions

Symptoms and General Pathology

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Wounds and Injuries

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Communicable Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hyperthermia

Pneumonia

Neutropenia

Fever

Febrile Neutropenia

Pneumonia, Pneumococcal

Pneumococcal Infections

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Respiratory Tract Infections

Lung Diseases

Respiratory Tract Diseases

Agranulocytosis

Leukopenia

Cytopenia

Leukocyte Disorders

Streptococcal Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Pneumonia, Bacterial

Granulocytopenia

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Anti-Bacterial Agents

Vaccines

Levofloxacin

Ofloxacin

Lenalidomide

Bortezomib

Daratumumab

Heptavalent Pneumococcal Conjugate Vaccine

Ixazomib

Immunologic Factors

Patients receiving novel agents (Bortezomib/Lenalidomide/Ixazomib/Daratumumab) and enrolled in vaccination by pneumococcal conjugate vaccine (PCV13): 3 doses with 1 month interval, and fourth dose planned to be administered 6 months later.

Patients receiving novel agents (Bortezomib/Lenalidomide/Ixazomib/Daratumumab) and receiving standard institutional antibacterial prophylaxis by Levofloxacin 500 mg daily during the median four cycles of treatment by novel agents

Vaccination with pneumococcal conjugate vaccine - PCV13 (Prevnar 13/Prevenar 13, Pfizer Inc) containing saccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F individually conjugated to nontoxic diphtheria cross-reactive material. Vaccination regimen: 3 doses monthly, with a booster dose 6 months later.

Vaccination with pneumococcal conjugate vaccine (PCV13)

Levofloxacin 500 mg once daily during the median four cycles of treatment by novel agents.

Standard Antibacterial Prophylaxis

Anatoly Uss, MD/PhD

Multiple myeloma is an incurable blood cancer of plasma cells that occurs in older individuals. Novel agents (proteasome inhibitors, immunomodulatory agents) have substantially improved the overall response rates, progression-free survival and overall survival in patients with multiple myeloma. Patients with multiple myeloma are at high risk of developing life-threatening Streptococcus pneumoniae infections, while clinical efficacy and safety of conjugate pneumococcal vaccines in multiple myeloma patients receiving novel agents have not been studied before. The main aim of this study is to assess the clinical efficacy and safety of 13-valent pneumococcal conjugate vaccine in multiple myeloma patients treated with novel agents.

Multiple myeloma is an incurable blood cancer of plasma cells that occurs in older individuals with a median age at diagnosis of 69 years and a median overall survival of 6-7 years \[Kumar S.K., et al. Leukemia, 2014; Rollig C., et al. Lancet., 2015\]. Over the past years novel agents have been introduced into clinical practice, showing improved overall response rates, progression-free survival and overall survival in patients with multiple myeloma. The main classes of novel agents include proteasome inhibitors, immunomodulatory agents and monoclonal antibodies. These agents are typically used in doublet or triplet regimens that include a chemotherapeutic drug and/or corticosteroid.

Streptococcus pneumoniae (pneumococcus) is a cause of worldwide morbidity and mortality. Patients with multiple myeloma are at high risk of developing life-threatening Streptococcus pneumoniae infections due to chemotherapy-associated immunosuppression. Vaccination is an important preventive strategy against infections caused by S. pneumoniae. In the past, the 23-valent pneumococcal polysaccharide vaccine was recommended. However, polysaccharide vaccines have limited efficacy in cancer and hematology patients, because of the decreased T- and B-cell responses. Clinical efficacy and safety of conjugate pneumococcal vaccines in multiple myeloma patients receiving novel agents have not been studied before.

In this study the investigators wish to study the effect of vaccination with 13-valent pneumococcal conjugate vaccine in multiple myeloma patients treated with novel agents (proteasome inhibitors and immunomodulatory drugs). The main aim of this study is to assess the clinical efficacy and safety of 13-valent pneumococcal conjugate vaccine in multiple myeloma patients treated with novel agents.

Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents

Data on Common Terminology Criteria for Adverse Events (CTCAE v4.0) will be collected via questionnaires. Measurement data will be aggregated in electronic platform to characterize the frequency, severity and interference of symptomatic treatment toxicities.

Belarusian State Medical University

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Head of Cell Transplant Division

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphatic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Molgramostim

Sargramostim

Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.

First vaccine dose subcutaneously, Day 0.

Starting with 3 doses of 250 micrograms subcutaneously, either pre or post vaccine. For pre vaccine, GM-CSF on days -7 (+ 1 day) and -3 (+ 1 day), in the week prior to vaccination for pre-vaccination immune priming; 3rd dose on the day of vaccination (day 0); and for post-vaccine GM-CSF given simultaneously on day of vaccination (day 0) and 2 more doses Day +3 and Day +7 after pneumococcal vaccine.

Sargramostim (GM-CSF)

Pneumococcal Vaccine

Amar Safdar, MD

The goal of this clinical research study is to see if Leukine(R) (sargramostim) improves the effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia, in patients with chronic lymphocytic leukemia (CLL).

Sargramostim (also commonly called granulocyte macrophage colony stimulating factor - GM-CSF) is a medication used to stimulate the bone marrow production of white blood cells before a stem cell transplant, after chemotherapy or after a bone marrow transplant. Pneumococcal vaccine is a medication used to prevent infections caused by a bacteria called Streptococcus pneumoniae.

If you have not had a gammaglobulins test (a test to measure immunity against certain infectious diseases) measured within three months before the study begins, then this blood test will be done before you receive any study medications.

Women who are able to have children must have a negative urine pregnancy test before starting treatment.

After consenting to this study, you will be randomly assigned (as in the toss of a coin) to receive treatment with sargramostim in addition to the pneumococcal vaccine or to receive pneumococcal vaccine alone (Prevnar).

* If you are randomized to vaccine plus sargramostim group, you will receive an injection of sargramostim at the same time you receive the pneumococcal vaccine.
* If you are randomized to the vaccine alone group, you will receive the pneumococcal vaccine on the first day.

Blood tests will be performed on the day of the pneumococcal vaccination, and 4 weeks, 12 weeks and 24 weeks after vaccination. Each of the blood tests will require about 4 teaspoons of blood. These blood tests will measure your immunity to pneumococcal infection.

If after 6 months of your first vaccination your body is not able to show immunity to pneumococcal infection, you will receive a second dose either pneumococcal vaccine plus sargramostim or pneumococcal vaccine alone. Your immunity will be checked again at 4 weeks, 12 weeks, and 24 weeks after this second dose. Only 4 teaspoon of blood will be required for the tests.

You may be removed from the study if you have a severe allergic reaction to the sargramostim and/or pneumococcal vaccine. The total maximum time you will be on this is study is 24 months.

This is an investigational study. Both of the medications used in this study are approved by the FDA. Up to 50 patients may be treated on this study. All will be enrolled at M.D. Anderson.

Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients

Immuno-Augmentation With GM-CSF in Patients Receiving Pneumococcal Vaccine While Undergoing Treatment for Advanced Chronic Lymphocytic Leukemia (CLL)

Response defined as 2-fold rise in anticapsular immunoglobulin G (IgG) when prevaccination titer is compared with levels post vaccination and with a final level of \>0.5 ug/mL. Anti-pneumococcal immunoglobulin titers measured at baseline and 1 month after vaccine. Response determined by measuring serum IgG to capsular polysaccharides from 6 of the most common infecting serotypes of Streptococcus pneumoniae.

Bayer

M.D. Anderson Cancer Center

Pneumococcal Vaccine + GM-CSF

Pneumococcal Vaccine Alone

Total

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Amar Safdar, MD/Professor

Pneumococcal Serotype 4

Pneumococcal Serotype 6B

Pneumococcal Serotype 9V

Pneumococcal Serotype 14

Pneumococcal Serotype 19F

Pneumococcal Serotype 23F

Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given pre vaccination Day -7, Day -1 and Day 0 (day of pneumococcal vaccine).

Pneumococcal Vaccine + Pre Vaccine GM-CSF

Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given Day 0 (day of pneumococcal vaccine), and post vaccination at Day +3 and Day +7.

Pneumococcal Vaccine + Post Vaccine GM-CSF

First vaccine dose subcutaneously, Day 0. No CM-CSF.

Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents	NCT03619252	Multiple Myelom... Pneumococcal In... Febrile Neutrop... Pneumococcal Pn...	Vaccination wit... Standard Antiba...	18 Years - 65 Years	Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients	NCT00323557	Leukemia	Sargramostim (G... Pneumococcal Va...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for pneumococcal pneumonia