Plasma Cell MyelomaEarly Phase 1NCT04211259
Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization
A Early Phase 1 study testing Loratadine and Questionnaire Administration in people with Plasma Cell Myeloma, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- Loratadine and Questionnaire Administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Apr 2022to 30 Jun 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Mansi R. Shah, MD, 732-235-4439, shahmr@cinj.rutgers.edu
Mansi Shah
- Not yet recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick
New Brunswick, New Jersey, 08903
About this study
Official title: The Prophylactic Use of Loratadine for Granulocyte-Colony Stimulating Factor (G-CSF) Induced Bone Pain in Multiple Myeloma Patients Undergoing Stem Cell Mobilization
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Plasma Cell Myeloma
- Being tested
- Loratadine, Placebo, Questionnaire Administration
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoratadineDrug
Also called Claritin
Given PO
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Loratadine; Other: 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. Receives: Other: Placebo; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 5 days after completion of stem cell mobilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start18 Apr 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mansi Shah, MD, Rutgers Cancer Institute of New Jersey
- Investigators
- Mansi R. Shah, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211259
- Sponsor's protocol ID
- 011910
- Other IDs
- NCI-2019-07795, Pro2019001846, Pro2019001846, P30CA072720
- Status last verified
- May 2026
- First submitted
- 23 Dec 2019
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No