Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Hematologic Neoplasms

Pain

Hematologic Diseases

Lymphosarcoma

All Drugs and Chemicals

Anti-Allergic Agents

Dermatologic Agents

Lenograstim

Loratadine

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine H1 Antagonists, Non-Sedating

Histamine Antagonists

Neurotransmitter Agents

LeAnne Kennedy, PharmD

The purpose of this project is to assess the efficacy of loratadine in decreasing the incidence and severity of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. This is a different patient population than those being assessed in current clinical trials.

Objectives

The primary objective is to determine the incidence of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. Incidence will be determined via patient-reported incidence following G-CSF administration.

Secondary objectives include determining the efficacy of loratadine for bone pain prevention as indicated by a decrease in incidence and a decrease in severity (questions 4 and 5 of the survey).

Evaluation of Loratadine for G-CSF Induced Bone Pain in Patients With Hematologic Malignancies

Evaluation of Loratadine for Granulocyte-Colony Stimulating Factor Induced Bone Pain in Patients With Hematologic Malignancies

Wake Forest University Health Sciences

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Beginning 5 days before the first dose of standard of care filgrastim, patients receive loratadine PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.

Beginning 5 days before the first dose of standard of care filgrastim, patients receive placebo PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.

Placebo

Questionnaire Administration

Mansi R. Shah, MD

Mansi Shah

This early phase I trial studies how well loratadine works in reducing granulocyte-colony stimulating factor (G-CSF) induced bone pain in patients with multiple myeloma who are undergoing stem cell mobilization. Loratadine is an antihistamine that may help to reduce or control bone pain during the process of stem cell collection in patients with multiple myeloma.

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of the second-generation antihistamine, loratadine, as prophylaxis for filgrastim (i.e., Neupogen, Zarxio) induced bone pain during stem cell mobilization in multiple myeloma patients.

SECONDARY OBJECTIVES:

I. To examine the frequency and quantity of supportive analgesic medications needed in addition to loratadine or placebo for filgrastim induced bone pain.

II. To identify risk factors associated with developing filgrastim induced bone pain.

OUTLINE: Patients are randomized to 1 of 2 cohorts.

COHORT I: Beginning 5 days before the first dose of standard of care filgrastim, patients receive loratadine orally (PO) once daily (QD). Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.

COHORT II: Beginning 5 days before the first dose of standard of care filgrastim, patients receive placebo PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.

Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization

The Prophylactic Use of Loratadine for Granulocyte-Colony Stimulating Factor (G-CSF) Induced Bone Pain in Multiple Myeloma Patients Undergoing Stem Cell Mobilization

Pain severity will be measured at baseline and following treatment using a 10-point scale, with higher numbers indicating greater degrees of pain. Will compare the difference in mean pain level for each group following therapy.

National Cancer Institute (NCI)

Rutgers, The State University of New Jersey

Assistant Professor of Medicine

Skin and Connective Tissue Diseases

Breast Neoplasms

Mastodynia

Breast Diseases

Skin Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Naproxen

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.

Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.

Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.

Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy.

Pegfilgrastim

The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.

Chemotherapy

The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.

In this study, the investigational products are naproxen, a non-steroidal antiinflammatory drug (NSAID), and loratadine, an anti-histamine. Both agents are being investigated as prophylactic medications to reduce the incidence and/or severity of bone pain in breast cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and pegfilgrastim prophylaxis.

Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help fight infections in patients undergoing chemotherapy.

NOLAN: Naproxen or Loratadine and Neulasta

Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim

Bone pain data were captured as part of standard adverse event (AE) reporting.

Bone pain data were captured as part of standard adverse event reporting. Severe bone pain is defined as grade 3 or 4 according to common terminology criteria for adverse events (CTCAE) version 3 grading criteria: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening or disabling.

Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Mean patient-reported bone pain values are the average of each participant's bone pain values across survey days 1-5 within each cycle. Across all cycles the mean is the average of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An analysis of variance (ANOVA) model with treatment as explanatory term was used.

Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Maximum patient-reported bone pain is the maximum of each participant's bone pain values across survey Days 1-5 within each cycle. Across all cycles the maximum is the maximum of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An ANOVA model with treatment as explanatory term was used.

Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from day 1 to 5 for each cycle. The AUC across cycles is the average of AUCs across the cycle.

Severity was graded using CTCAE version 3. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal; • life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • congenital anomaly/birth defect; • other medically important serious event.

The investigator assessed each adverse event for relatedness to investigational product(s) or other protocol-required therapies.

Amgen

Participants in the Naproxen or Loratadine groups who did not receive naproxen or loratadine are analyzed in the No Prophylaxis group for safety analyses.

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.

No Prophylactic Intervention

Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.

Naproxen 500mg BID

Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.

Loratadine 10mg QD

No Prophylaxis

Naproxen 500 mg BID

Loratadine 10 mg QD

Total

Age, Continuous

Sex: Female, Male

Hispanic/Latino

Not Hispanic/Latino

Race/Ethnicity, Customized

American Indian or Alaska Native

Asian

Black (or African American)

Multiple

Native Hawaiian or Other Pacific Islander

White

Other

Full analysis set included all participants based on the randomization treatment group who received primary prophylaxis with pegfilgrastim.

Study Director

Percentage of Participants With Bone Pain (All Grades) in Cycle 1

Cycle 2 (n=178, 180, 193)

Cycle 3 (n=165, 176, 188)

Cycle 4 (n=162, 169, 179)

Across All Cycles (n=191, 196, 200)

Full analysis set; "n" indicates the number of participants who entered each cycle.

Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles

Cycle 1 (n=191, 196, 200)

Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles

Across all Cycles (n=191, 196, 200)

Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. "n" indicates the number of participants who entered each cycle.

Mean Patient-reported Bone Pain by Cycle and Across Cycles

Maximum Patient-reported Bone Pain by Cycle and Across Cycles

Area Under the Curve (AUC) for Patient-reported Bone Pain

Any adverse event

Worst grade of ≥ 2

Worst grade of ≥ 3

Worst grade of ≥ 4

Serious adverse events

Fatal adverse events

AE leading to discontinuation from study

SAE leading to discontinuation from study

Any adverse event related to IP

SAE related to IP

AE related to IP leading to discontinuation of IP

SAE related to IP leading to discontinuation of IP

Any adverse event related to pegfilgrastim

SAE related to pegfilgrastim

AE related to / leading to discontinuation of Peg

SAE related to / leading to discontinuation of Peg

Safety analysis set included all participants who received primary prophylaxis with pegfilgrastim according to the prophylactic medication actually received. Participants in the Naproxen or Loratadine groups who did not receive naproxen or loratadine are analyzed in the No Prophylaxis group for safety analyses.

Number of Participants With Adverse Events (AEs)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Loratadine for G-CSF Induced Bone Pain in Patients With Hematologic Malignancies	NCT02305979	Leukemia Lymphoma	Loratadine	18 Years -	Wake Forest University Health Sciences
Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization	NCT04211259	Plasma Cell Mye...	Loratadine Placebo Questionnaire A...	18 Years -	Rutgers, The State University of New Jersey
NOLAN: Naproxen or Loratadine and Neulasta	NCT01712009	Bone Pain in St...	Naproxen Loratadine Pegfilgrastim Chemotherapy	18 Years - 100 Years	Amgen

Spots Global Cancer Trial Database for loratadine

Every month we try and update this database with for loratadine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for loratadine

Every month we try and update this database with for loratadine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for loratadine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.