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

This study has suspended participant recruitment.
(due to protocol amendment)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01676961
First received: August 29, 2012
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Thrombocytopenia
Biological: romiplostim
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Percentage of patients who have responded [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Response is defined as platelet increases to greater than 50 x 10^9/L for more than 2 weeks.


Secondary Outcome Measures:
  • Percentage of patients who experienced thrombosis or marrow fibrosis [ Time Frame: Up to 1.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 14
Study Start Date: January 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676961

Locations
United States, New York
NYU Cancer Institute
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Amitabha Mazumder New York University School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01676961     History of Changes
Other Study ID Numbers: NYU 10-02429, P30CA016087
Study First Received: August 29, 2012
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014