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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01676961
Recruitment Status : Terminated (PI left the institution)
First Posted : August 31, 2012
Results First Posted : September 5, 2017
Last Update Posted : September 5, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
New York University School of Medicine

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

Condition or disease Intervention/treatment Phase
Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma Thrombocytopenia Biological: romiplostim Phase 2

Detailed Description:


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.


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.


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase II Trial Evaluating the Efficacy and Safety of Romiplostim (Nplate) Treatment of Chemotherapy Induced Thrombocytopenia in Patients With Multiple Myeloma
Study Start Date : January 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Romiplostim

Arm Intervention/treatment
Experimental: Supportive care (romiplostim)
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..
Biological: romiplostim
Given SC
Other Names:
  • AMG 531
  • Amgen megakaryopoiesis protein 2
  • Nplate

Primary Outcome Measures :
  1. Percentage of Patients Who Have Responded [ Time Frame: 8 weeks ]
    Response is defined as platelet increases to greater than 50 x 10^9/L for more than 2 weeks.

Secondary Outcome Measures :
  1. Percentage of Patients Who Experienced Thrombosis or Marrow Fibrosis [ Time Frame: Up to 1.5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01676961

United States, New York
NYU Cancer Institute
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Cancer Institute (NCI)
Principal Investigator: Amitabha Mazumder New York University School of Medicine

Responsible Party: New York University School of Medicine Identifier: NCT01676961     History of Changes
Other Study ID Numbers: 10-02429
P30CA016087 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2012    Key Record Dates
Results First Posted: September 5, 2017
Last Update Posted: September 5, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Blood Platelet Disorders