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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01676961
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 34
• Patients Per Site Per Month: 0.1

Study Details

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

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

PRIMARY OBJECTIVES:

1. 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:

1. To evaluate the toxicity of romiplostim in this patient population by standard Common Toxicity Criteria (CTC).

2. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• 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: Jan 1, 2013
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Who Have Responded [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 [Up to 1.5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Cancer Institute	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Amitabha Mazumder, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01676961
• Other Study ID Numbers: 10-02429; P30CA016087
• First Posted: Aug 31, 2012
• Last Update Posted: Oct 15, 2018
• Last Verified: Sep 1, 2018

• 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; Thrombocytopenia

Study Results

Participant Flow

Arm/Group Title	Supportive Care (Romiplostim)
Arm/Group 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.. romiplostim: Given SC
Period Title: Overall Study
STARTED	5
COMPLETED	0
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Supportive Care (Romiplostim)
Arm/Group 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.. romiplostim: Given SC
Overall Participants	5
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	5 100%
Region of Enrollment (Count of Participants)
United States	5 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Who Have Responded
Description	Response is defined as platelet increases to greater than 50 x 10^9/L for more than 2 weeks.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Data was not analyzed. Dr. Mazumder left institution and data was not analyzed.

Arm/Group Title	Supportive Care (Romiplostim)
Arm/Group 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.. romiplostim: Given SC
Measure Participants	0

2. Secondary Outcome

Title	Percentage of Patients Who Experienced Thrombosis or Marrow Fibrosis
Time Frame	Up to 1.5 years

Outcome Measure Data

Analysis Population Description

Patient data was not analyzefd

Arm/Group Title	Supportive Care (Romiplostim)
Arm/Group 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.. romiplostim: Given SC
Measure Participants	0

Adverse Events

Time Frame	4 Months
Arm/Group Title	Supportive Care (Romiplostim)
Arm/Group 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.. romiplostim: Given SC
All Cause Mortality
	Supportive Care (Romiplostim)
	Affected / at Risk (%)	# Events
Total	4/5 (80%)
Serious Adverse Events
	Supportive Care (Romiplostim)
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Supportive Care (Romiplostim)
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.