What side effects are associated with this type of intervention?

Thrombopoietin receptor agonists, such as Romiplostim, are used to treat thrombocytopenia by stimulating platelet production. Known side effects include the formation of antibodies against the drug, which can reduce its effectiveness. Other potential toxicities include bone marrow reticulin formation, which can lead to fibrosis, and an increased risk of thromboembolic events, particularly in patients with underlying thrombophilia. Additionally, there are concerns about the exacerbation of thromboembolic disease and the cost of treatment. Overall, while effective in increasing platelet counts, these treatments must be carefully monitored for adverse effects.

What prior FDA approvals exist?

Romiplostim, a thrombopoietin receptor agonist, has been approved by the FDA for the treatment of thrombocytopenia in various conditions, including chronic immune thrombocytopenia (ITP) and chemotherapy-induced thrombocytopenia. Another similar drug, eltrombopag, has also received FDA approval for treating chronic ITP, severe aplastic anemia, and thrombocytopenia in patients with chronic hepatitis C. Both drugs work by stimulating the production of platelets, thereby helping to manage low platelet counts in patients with these conditions.

What other types of research exist?

Promising novel alternatives to Romiplostim for thrombocytopenia patients in 2024 include Eltrombopag and Avatrombopag. Eltrombopag is an oral thrombopoietin receptor agonist effective in treating chronic immune thrombocytopenia, thrombocytopenia in patients with hepatitis C, and refractory severe aplastic anemia. Avatrombopag is another oral thrombopoietin receptor agonist shown to be effective in patients with chronic liver disease and those undergoing elective procedures. Both alternatives have demonstrated efficacy and safety in clinical trials.

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Romiplostim for Chemotherapy-Induced Low Platelet Count

Phase 3

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be at least 21 or 28 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if receiving a 21-day or 28-day cycle chemotherapy regimen, respectively.

Documented active stage I, II, III or IV locally advanced or metastatic of the following tumor types: NSCLC, breast cancer, or ovarian cancer (includes fallopian tube epithelial carcinomas and peritoneal epithelial carcinoma of unknown primary), or any stage recurrent disease. Patients with documented locally advanced (stage III) NSCLC should not be amenable to definitive treatment with chemoradiation and/or surgery.

Must not have

History of arterial thrombotic events (eg, myocardial ischemia, transient ischemic attack, or stroke) within 6 months prior to screening.

Acute lymphoblastic leukemia.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Pivotal Trial

Summary

This trial tests romiplostim, a drug that boosts platelet production, in adults with certain cancers undergoing chemotherapy. It aims to help these patients maintain their chemotherapy schedule by increasing their platelet counts. Romiplostim has shown effectiveness in increasing platelet counts in patients with low platelet levels due to chemotherapy.

Who is the study for?

Adults over 18 with advanced or recurrent NSCLC, breast, or ovarian cancer eligible for chemotherapy can join. They must have low platelet counts due to chemo and be able to undergo at least 3 more cycles. Exclusions include HIV, recent heart issues, other cancers within 5 years (with exceptions), active infections, certain blood disorders, and unwillingness to use contraception.

What is being tested?

The trial is testing Romiplostim's effectiveness in treating low platelet counts caused by chemotherapy in patients with NSCLC, ovarian cancer, or breast cancer. The goal is to see if it helps them receive full-dose chemo on schedule without delays.

What are the potential side effects?

Romiplostim may cause side effects like headache, dizziness, insomnia; muscle or joint pain; nausea or vomiting; fever; and an increased risk of blood clots. It might also lead to bone marrow changes resulting in abnormal blood cell levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I finished my last chemotherapy cycle at least 21 or 28 days ago, depending on the cycle length.

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My cancer is advanced or has returned and includes lung, breast, or ovarian cancer.

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I have at least 3 chemotherapy sessions left.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a heart attack, mini-stroke, or stroke in the last 6 months.

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I have acute lymphoblastic leukemia.

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I have acute myeloid leukemia.

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I haven't had any new or uncontrolled blood clots in the last 3 months.

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I have a type of blood cancer known as myeloid malignancy.

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I have not had major surgery in the last 28 days or minor surgery in the last 3 days.

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I agree not to donate sperm during and for 7 months after treatment.

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I have used certain medications or experimental treatments for platelet production.

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I am not pregnant, breastfeeding, nor planning to during and for 7 months after treatment.

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I have an active hepatitis B or C infection.

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I haven't had serious heart issues or a heart attack in the last 4 months.

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I have been diagnosed with myelodysplastic syndrome.

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I have a disorder where my bone marrow makes too many blood cells.

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I am willing to use effective birth control during and 7 months after treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of either a chemotherapy dose delay or reduction

Secondary study objectives

Depth of Platelet Count

Number of subjects who develop anti-TPO antibodies

Number of subjects who develop anti-romiplostim antibodies

+8 more

Side effects data

From 2010 Phase 3 trial • 313 Patients • NCT00116688

37%

Headache

34%

Nasopharyngitis

32%

Fatigue

30%

Contusion

26%

Upper respiratory tract infection

25%

Diarrhoea

25%

Epistaxis

24%

Cough

24%

Nausea

24%

Arthralgia

19%

Pain in extremity

19%

Back pain

18%

Dizziness

18%

Petechiae

17%

Oropharyngeal pain

16%

Vomiting

15%

Gingival bleeding

15%

Rash

14%

Insomnia

14%

Oedema peripheral

13%

Haematoma

13%

Sinusitis

12%

Myalgia

12%

Pyrexia

12%

Urinary tract infection

11%

Abdominal pain

11%

Pain

10%

Paraesthesia

10%

Musculoskeletal pain

10%

Muscle spasms

10%

Idiopathic thrombocytopenic purpura

10%

Nasal congestion

Rhinorrhoea

Constipation

Ecchymosis

Thrombocytopenia

Dyspnoea

Influenza

Bronchitis

Pruritus

Asthenia

Depression

Oropharyngeal blistering

Fall

Abdominal pain upper

Dyspepsia

Anxiety

Blood blister

Mouth haemorrhage

Procedural pain

Anaemia

Abdominal discomfort

Skin lesion

Hypertension

Toothache

Skin laceration

Dysuria

Migraine

Injection site haematoma

Seasonal allergy

Chest pain

Joint swelling

Joint sprain

Gastroenteritis

Ear infection

Chills

Excoriation

Pneumonia

Myocardial infarction

Cardiac failure congestive

Viral infection

Viral upper respiratory tract infection

Arthropod bite

Atrial fibrillation

Vertigo

Dehydration

Colitis

Renal failure acute

Bone marrow disorder

Cellulitis

Syncope

Osteoarthritis

Respiratory failure

Hepatic neoplasm malignant

Catheter related infection

Mouth ulceration

Hyperkalaemia

Cholelithiasis

Gastrointestinal haemorrhage

Urosepsis

Knee arthroplasty

Hepatic failure

Appendicitis

Platelet count increased

Hip fracture

Transient ischaemic attack

Angina unstable

Coronary artery disease

Mental status changes

Renal failure

Vaginal haemorrhage

Cardiac failure

Cholecystitis

Convulsion

Acute myocardial infarction

Hernia obstructive

Rectal haemorrhage

Platelet count decreased

Cerebrovascular accident

Deep vein thrombosis

Animal bite

100%

80%

60%

40%

20%

Study treatment Arm

Romiplostim in Adults

Romiplostim in Pediatric Population

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RomiplostimExperimental Treatment1 Intervention

The study in a 2:1 randomization ratio(108 subjects to romiplostim). Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

Group II: PlaceboPlacebo Group1 Intervention

The study in a 2:1 randomization ratio (54 subjects to placebo) Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Romiplostim

2015

Completed Phase 3

~2240

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Thrombopoietin receptor agonists, such as Romiplostim, work by mimicking the action of thrombopoietin, a hormone that stimulates the production of platelets from megakaryocytes in the bone marrow. This mechanism is crucial for thrombocytopenia patients as it helps to elevate platelet counts, thereby reducing the risk of bleeding and enabling the continuation of essential treatments like chemotherapy. Other common treatments for thrombocytopenia include platelet transfusions, which provide immediate but temporary relief, and immunosuppressive therapies that reduce the destruction of platelets in immune-mediated cases. These treatments collectively aim to manage and mitigate the symptoms and risks associated with low platelet counts.