NCT04211259

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Apr 2022

Typical duration for early_phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
2.3 years until next milestone

Study Start

First participant enrolled

April 18, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

1.9 years

First QC Date

December 23, 2019

Last Update Submit

August 3, 2023

Conditions

Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

  • Change in mean pain level for each group following therapy

    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.

    Baseline up to 5 days after completion of stem cell mobilization

Study Arms (2)

Cohort I (loratadine)

EXPERIMENTAL

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.

Drug: LoratadineOther: Questionnaire Administration

Cohort II (placebo)

PLACEBO COMPARATOR

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.

Other: PlaceboOther: Questionnaire Administration

Interventions

LoratadineDRUG

Given PO

Also known as: Claritin
Cohort I (loratadine)
PlaceboOTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy
Cohort II (placebo)
Questionnaire AdministrationOTHER

Ancillary studies

Cohort I (loratadine)Cohort II (placebo)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must be able to provide informed consent
  • Patients with confirmed diagnosis of multiple myeloma
  • Able to swallow and retain oral medication
  • All ethnic groups are eligible

You may not qualify if:

  • Non-English speaking person
  • Patients undergoing haploidentical allogeneic hematopoietic stem cell transplant
  • Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
  • Any medical complications or conditions that would, in the investigator's judgement, interfere with full participation in the study
  • On therapeutic dose of aspirin (doses greater than 81 mg) within 7 days prior to the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick

New Brunswick, New Jersey, 08903, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Loratadine

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

CyproheptadineDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Mansi R. Shah, MD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mansi R. Shah, MD

CONTACT

732-235-4439shahmr@cinj.rutgers.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

December 23, 2019

First Posted

December 26, 2019

Study Start

April 18, 2022

Primary Completion

February 28, 2024

Study Completion

June 30, 2025

Last Updated

August 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)