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Thrombopoietin Receptor Agonist

Romiplostim for Multiple Myeloma

Phase 2
Waitlist Available
Led By Michael Scordo, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 days from ahct
Awards & highlights

Study Summary

This trial will test whether a drug can help with low platelet counts caused by standard blood cancer treatment, as well as reducing the number of times patients need transfusions.

Eligible Conditions
  • Multiple Myeloma
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Hematopoietic Stem Cell Transplantation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 days from ahct
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days from ahct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Days Post HDT-AHCT Requiring Transfusions or Grade 4 CTCAE Thrombocytopenia
Secondary outcome measures
Number of Platelet Transfusions Per Participant Issued During the AHCT Admission

Side effects data

From 2010 Phase 3 trial • 313 Patients • NCT00116688
50%
Upper respiratory tract infection
45%
Cough
45%
Headache
45%
Pyrexia
45%
Petechiae
40%
Contusion
35%
Fatigue
35%
Vomiting
30%
Nasal congestion
30%
Oropharyngeal pain
25%
Gingival bleeding
25%
Rhinorrhoea
25%
Epistaxis
25%
Rash
25%
Nasopharyngitis
25%
Arthralgia
20%
Abdominal pain upper
20%
Pain
20%
Mouth haemorrhage
20%
Nausea
15%
Abdominal pain
15%
Excoriation
15%
Myalgia
15%
Viral upper respiratory tract infection
10%
Dyspnoea
10%
Ear infection
10%
Idiopathic thrombocytopenic purpura
10%
Pain in extremity
10%
Diarrhoea
10%
Chills
10%
Joint sprain
10%
Gastroenteritis
10%
Scab
10%
Dizziness
10%
Mouth ulceration
10%
Viral infection
10%
Animal bite
10%
Arthropod bite
10%
Procedural pain
5%
Anaemia
5%
Migraine
5%
Constipation
5%
Musculoskeletal pain
5%
Haematoma
5%
Abdominal discomfort
5%
Muscle spasms
5%
Pharyngitis streptococcal
5%
Seasonal allergy
5%
Influenza
5%
Bronchitis
5%
Ecchymosis
5%
Skin lesion
5%
Toothache
5%
Chest pain
5%
Sinusitis
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Romiplostim in Pediatric Population
Romiplostim in Adults

Trial Design

1Treatment groups
Experimental Treatment
Group I: romiplostimExperimental Treatment1 Intervention
Patients will be enrolled prior to admission for High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT), and they will undergo their planned HDT-AHCT for their respective hematologic malignancy as per institutional standards. Regardless of the conditioning regimen received, all patients will receive romiplostim 3.0 mcg/kg SC on Day +1 and romiplostim 2.0 mcg/kg SC on Day +8 after HDT-AHCT. Beyond Day +8, patients will be treated until platelet count is >50,000/mcL, without any platelet transfusions in the prior 48 hours. All doses after the second romiplostim dose will be titrated as per Table 3, based on weekly CBC/platelet counts. No patient will receive more than six doses of romiplostim, even if platelets have not corrected by Day +42.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Romiplostim
2015
Completed Phase 3
~2290

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,317 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,105 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,367 Previous Clinical Trials
1,386,191 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,678 Patients Enrolled for Multiple Myeloma
Michael Scordo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
45 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you describe the past experiments involving Romiplostim?

"Romiplostim was first put under the microscope in 2014 by Memorial Sloan Kettering Bergen. Currently, there are 9 trials ongoing and 41 studies that have been completed. Notably, a considerable quantity of these investigations is being conducted at Uniondale, NJ."

Answered by AI

Has the Food and Drug Administration sanctioned Romiplostim for human use?

"Due to the fact that Romiplostim is in Phase 2 clinical trials, our team at Power considers this drug's safety level to be a moderate-level 2 given its lack of efficacy data."

Answered by AI

How many participants is the trial currently enrolling?

"This clinical trial has ceased its search for participants; the original post was published in July 2020 and the last update on March 2022. Fortunately, there are 2441 trials seeking patients with multiple myeloma as well as 9 studies needing volunteers to test out romiplostim."

Answered by AI

Is this a pioneering clinical trial?

"Since 2014, Amgen has sponsored research into the efficacy of romiplostim. The initial clinical trial involved sixty participants and granted Romiplostim its Phase 2 drug approval. Currently 9 studies are ongoing in 62 cities distributed across 23 countries."

Answered by AI

How many venues are providing access to this experiment?

"This medical trial is currently being conducted in seven different locations, including Memorial Sloan Kettering Nassau (Limited Protocol Activities) in Uniondale, Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown and Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities). Other centres are also participating."

Answered by AI

Is enrollment still open for this medical research study?

"The information on clinicaltrials.gov indicates that this particular trial is no longer actively seeking patients, as the posting was initially created on July 14th 2020 and most recently updated on March 7th 2022. Nonetheless, there are currently 2450 other medical experiments searching for volunteers to join their research teams."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer
2020. "Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04478123.
~13 spots leftby Apr 2025
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