Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00400686
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 31
• Location: 1
• Arm: 1
• Duration (Months): 119
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia in patients with multiple myeloma.

PURPOSE: This clinical trial is studying how well epoetin alfa works in treating anemia in patients undergoing chemotherapy for multiple myeloma.

Condition or Disease	Intervention/Treatment	Phase
Anemia; Multiple Myeloma; Plasma Cell Neoplasm	Biological: epoetin alfa	N/A

Detailed Description

OBJECTIVES:

Primary

• Determine the hematologic response and transfusion requirements of chemotherapy-related moderate anemia to the administration of a high initial dose of epoetin alfa followed by a less frequent maintenance dose of epoetin alfa in multiple myeloma patients.

Secondary

• Determine the effect of moderate anemia on quality of life in these patients.

• Correlate changes in hemoglobin levels with changes in quality of life in patients treated with this drug.

• Determine the effect of this drug on transfusion requirements after day 28 in these patients.

OUTLINE: This is an open-label, non-randomized, pilot study.

Patients receive high-dose epoetin alfa subcutaneously (SC) once a week for 4 weeks or until their hemoglobin levels reach 12-13 g/dL. Patients then receive epoetin alfa SC once every 2 weeks for 8 weeks OR once a week for 4 weeks, and then once every 2 weeks for 8 weeks (as long as their hemoglobin levels remain between 12-13 g/dL). Patients then receive maintenance epoetin alfa SC once every 4 weeks for up to 12 weeks.

Patients whose hemoglobin level decreases by 1-1.5 g/dL return to previous epoetin alfa schedule. Patients whose hemoglobin level is < 9 g/dL after returning to the previous schedule may receive epoetin alfa for an additional 24 weeks.

Quality of life is assessed at baseline and at weeks 2, 4, 8, 16, and 24 weeks during treatment.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Single Institution, Open-Label, Nonrandomized Pilot Study of High Dose Epoetin Alfa Administered Once a Week in Patients With Multiple Myeloma: Its Effects on Hemoglobin, Blood Transfusion Requirements and Quality of Life
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epoetin Alfa - 80,000 U sc Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels	Biological: epoetin alfa; Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Hemoglobin at Day 28 [Baseline to Day 28]

   Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.

2. Number of Patients With an at Least 1gm/dL Increase in Hgb [Baseline to Day 28]

3. Number of Patients With an at Least 2gm/dL Increase in Hgb [Baseline to Day 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed multiple myeloma (MM)

• Requiring active therapy for MM

• Planning to undergo chemotherapy for ≥ 3 months

• Moderate anemia caused by MM and/or chemotherapy, as evidenced by hemoglobin ≤ 11.0 g/dL

• No untreated anemia predominantly due to factors other than MM/chemotherapy (i.e., iron or folate deficiencies, hemolysis, HIV, or gastrointestinal bleeding)

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-3

• Life expectancy ≥ 6 months

• Transferrin saturation ≥ 20%

• Ferritin ≥ 100 ng/mL

• Homocysteine normal (concurrent vitamin supplementation allowed)

• Methylmalonic acid normal (concurrent vitamin supplementation allowed)

• Renal function normal

• No uncontrolled hypertension

• No prior thrombotic events unless treated with appropriate prophylaxis

• No known hypersensitivity to mammalian cell-derived products

• No uncontrolled infection

• No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Weight < 100 Kg

• Patients with iron, folate, or vitamin B_12 deficiency allowed provided conditions are corrected prior to study entry

• Able to read and understand English at a 7th grade level

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior total lymphoid, extensive abdominal, or inverted Y radiotherapy

• Concurrent red blood cell transfusion allowed provided hemoglobin ≤ 7 g/dL AND patient is symptomatic

• Concurrent vitamin supplementation allowed for cyanocobalamin (vitamin B_12) or folate deficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065

Sponsors and Collaborators

• The Cleveland Clinic
• National Cancer Institute (NCI)

Investigators

• Study Chair: Ronald M. Sobecks, MD, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00400686
• Other Study ID Numbers: CASE-CCF-5497; P30CA043703; CASE-CCF-5497; ORTHO-CASE-CCF-5497
• First Posted: Nov 17, 2006
• Last Update Posted: Feb 22, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by The Cleveland Clinic: anemia; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Anemia; Epoetin Alfa

Study Results

Participant Flow

Recruitment Details	From 9/2003 to 6/2008, a total of 31 patients were enrolled.

Arm/Group Title	Epoetin Alfa - 80,000 U sc
Arm/Group Description	Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
Period Title: Overall Study
STARTED	31
COMPLETED	31
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Epoetin Alfa - 80,000 U sc
Arm/Group Description	Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
Overall Participants	31
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	61.9
Sex: Female, Male (Count of Participants)
Female	12 38.7%
Male	19 61.3%
Region of Enrollment (participants) [Number]
United States	31 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Hemoglobin at Day 28
Description	Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.
Time Frame	Baseline to Day 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epoetin Alfa - 80,000 U sc
Arm/Group Description	Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
Measure Participants	31
Median (Full Range) [g/dL]	1.3

2. Primary Outcome

Title	Number of Patients With an at Least 1gm/dL Increase in Hgb
Time Frame	Baseline to Day 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epoetin Alfa - 80,000 U sc
Arm/Group Description	Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
Measure Participants	31
Number [participants]	13 41.9%

3. Primary Outcome

Title	Number of Patients With an at Least 2gm/dL Increase in Hgb
Time Frame	Baseline to Day 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epoetin Alfa - 80,000 U sc
Arm/Group Description	Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
Measure Participants	31
Number [participants]	9 29%

Adverse Events

Time Frame	AE data highlights development of VTEs in patients receiving one of the following: 1. lenalidomide, high dose dexamethasone & Aspirin 325mg daily 2. thalidomide & doxil based therapy with aspirin 81mg daily 3. cyclophosphamide & prednisone without VTE
Adverse Event Reporting Description	Only immediately reportable Serious Adverse Events (SAE) & Venous thrombolytic event (VTE) were captured for the purpose of this study.
Arm/Group Title	Epoetin Alfa - 80,000 U sc
Arm/Group Description	Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
All Cause Mortality
	Epoetin Alfa - 80,000 U sc
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Epoetin Alfa - 80,000 U sc
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Other (Not Including Serious) Adverse Events
	Epoetin Alfa - 80,000 U sc
	Affected / at Risk (%)	# Events
Total	3/31 (9.7%)
Blood and lymphatic system disorders
Venous Thromboembolic Event (VTE)	3/31 (9.7%)	3

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.