Skip to content
Triangle logo TriangleGet started
← Study library

NCT01676961 · REGISTRY CONDITION SEARCH

Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2018-10-15

This phase II trial studies how well romiplostim works in increasing low platelet counts in patients with multiple myeloma receiving chemotherapy. Romiplostim may cause the body to make platelets after chemotherapy

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Percentage of Patients Who Have Responded

→

outcome · POSTED

Percentage of Patients Who Experienced Thrombosis or Marrow Fibrosis

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care * Subject is not pregnant or breast feeding, and cannot become pregnant within 30 days after the end of treatment * Female subject of child bearing potential must be willing to use, in combination with her partner, 2 forms highly effective contraception during treatment and for 1 month after the end of treatment * Diagnosis of any stage of multiple myeloma based on standard criteria as follows: * Major criteria 1. Plasmacytomas on tissue biopsy 2. Bone marrow plasmacytosis (\> 30% plasma cells) 3. Monoclonal immunoglobulin spike on serum electrophoresis (immunoglobin G \[IgG\] \> 3.5 G/dL or immunoglobin A \[IgA\] \> 2.0 G/dL) or kappa or lambda light chain excretion \> 1 G/day on 24 hour urine protein electrophoresis * Minor criteria 1. Bone marrow plasmacytosis (10 to 30% plasma cells) 2. Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria 3. Lytic bone lesions 4. Normal immunoglobin M (IgM) \< 50 mg/dL, IgA \< 100 mg/dL, or IgG \< 600 mg/dL * Any of the following sets of criteria will confirm the diagnosis of multiple myeloma: * Any two of the major criteria * Major criterion 1 plus minor criterion b, c, or d * Major criterion 3 plus minor criterion a or c * Minor criteria a, b and c or a, b and d * Karnofsky performance status \>= 50 * Platelet count =\< 50 x 10\^9/L untransfused of at least 2 weeks duration, secondary to prior chemotherapy. If there is a platelet count of \> or = 50 x 10(9)/L after a transfusion, that value will be discounted. This may include a combination regimen including lenalidomide; these regimens will include dexamethasone, cyclophosphamide, etoposide, cisplatin (DCEP), Velcade with Doxil, Cytoxan and/or lenalidomide; patients who have thrombocytopenia (CIT) from lenalidomide or from radiation therapy alone will not be allowed * Calculated or measured creatinine clearance \>= 30 mL/min Exclusion Criteria: * POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\] and skin changes) * Plasma cell leukemia * Receiving steroids daily for other medical conditions, e.g., asthma, systemic lupus erythematosus, rheumatoid arthritis * Infection not controlled by antibiotics * Human immunodeficiency virus (HIV) infection; patients should provide consent for HIV testing according to the institution's standard practice * Known active hepatitis B or C * Patient had myocardial infarction within 6 months prior to enrollment, New York Hospital Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant * Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy * Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol * Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women * Patient has \> 1.5 x upper limit of normal (ULN) total bilirubin * Patients with existing deep venous thrombosis will be excluded * Patients receiving maintenance therapy with myelosuppressive medications such as lenalidomide will be excluded
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count \> 50 x 10\^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..
    intervention Names
    1. Biological: romiplostim
    label
    Supportive care (romiplostim)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Supportive care (romiplostim)
    description
    Given SC
    name
    romiplostim
    other Names
    1. AMG 531
    2. Amgen megakaryopoiesis protein 2
    3. Nplate
    type
    BIOLOGICAL
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
5
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Response is defined as platelet increases to greater than 50 x 10\^9/L for more than 2 weeks.
    measure
    Percentage of Patients Who Have Responded
    time Frame
    8 weeks
secondary Outcomes
  1. measure
    Percentage of Patients Who Experienced Thrombosis or Marrow Fibrosis
    time Frame
    Up to 1.5 years
Full study description
brief Summary
This phase II trial studies how well romiplostim works in increasing low platelet counts in patients with multiple myeloma receiving chemotherapy. Romiplostim may cause the body to make platelets after chemotherapy
detailed Description
PRIMARY OBJECTIVES: I. To determine if Nplate (romiplostim) is capable of increasing platelet counts to \> 50 x 10\^9/L for greater than 2 weeks in myeloma patients with chemotherapy induced thrombocytopenia. SECONDARY OBJECTIVES: I. To evaluate the toxicity of romiplostim in this patient population by standard Common Toxicity Criteria (CTC). II. To determine any increase in thrombosis or marrow fibrosis. OUTLINE: Patients receive romiplostim subcutaneously (SC) once weekly for up to 6 weeks. Patients achieving a platelet count \> 50 x 10\^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen. After completion of study treatment, patients are followed up every 3 months for 1 year.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-abbfb8db5c395dc541b4
      requested nct id
      NCT01676961
      primary nct id
      NCT01676961
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      513fa6793d69449c1bcfed1827174157204812e56625f091581203dca8ce6c61
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-abbfb8db5c395dc541b4
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01676961
      occurrences
      1. context exact
        NCT01676961
        end
        11
        exact text
        NCT01676961
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/965/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      ce8a657fc5b334296b3732f0401c30098eb0f3c6e7006485c0e17cbd81c636a2

    Preserved source evidence · Not medical advice