NCT02608060

Brief Summary

This study will examine the efficacy, safety and effect on hemoglobin levels, of once weekly subcutaneous injections of epoetin beta (30,000 IU) in anemic participants with non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma. The anticipated study duration is 4 months, and the target sample size is 30 individuals.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

November 16, 2015

Last Update Submit

November 1, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin levels at 16 weeks

    16 Weeks

Secondary Outcomes (6)

  • Serum Iron, Ferritin and Transferrin Levels

    16 Weeks

  • Time to Global Response

    Up to 4 months

  • Percentage of Participants with a Positive Response

    Weeks 4 and 8

  • Quality of Life in Relation to Grade of Anemia

    Up to 4 months

  • Quality of Life According to the Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument

    Up to 4 months

  • +1 more secondary outcomes

Study Arms (1)

Epoetin Beta - 30000 IU

EXPERIMENTAL

Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.

Drug: Epoetin Beta

Interventions

Epoetin BetaDRUG

Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 g/dL versus baseline.

Also known as: Recormon
Epoetin Beta - 30000 IU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult participants with a diagnosis of non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma
  • Anemia at Screening Visit

You may not qualify if:

  • Transfusion of red blood cells within 2 months of study drug
  • Treatment-resistant hypertension
  • Acute or chronic bleeding (requiring therapy) within 3 months of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Caracas, 1040, Venezuela

Location

Unknown Facility

Caracas, 2122, Venezuela

Location

MeSH Terms

Conditions

Anemia

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 18, 2015

Study Start

September 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

VE(2)