Phase 3
N=490
Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer
Anemia · Leukemia · Lymphoma · Lymphoproliferative Disorder · Multiple Myeloma and Plasma Cell Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT00661999 ↗Enrolled (actual)
490
Serious AEs
2.0%
Results posted
Apr 2011
Primary outcome: Primary: Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response — 114; 109; 106; 50 Participants — p=0.39
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- darbepoetin alfa (Biological); ferrous sulfate (Dietary_supplement); sodium ferric gluconate complex in sucrose (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response |
114; 109; 106; 50; 54; 57 | 0.39 |
| SECONDARY Percentage of Patients Maintaining an Average Hemoglobin Level Within the National Comprehensive Cancer Network (NCCN) Range (11-13 g/dL) Through Week 16, Once Achieving a Hemoglobin of ≥ 11 g/dL |
10; 12; 11 | — |
| SECONDARY Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions |
20; 21; 22; 144; 142; 141 | 0.7250 |
| SECONDARY Mean Increment in Hemoglobin Level at Week 7 |
1.3; 1.1; 1.2 | 0.6639 |
| SECONDARY Mean Increment in Hemoglobin Level at Week 16 |
2.1; 2.0; 1.7 | 0.1124 |
| SECONDARY Time to Hematopoietic Response |
43; 61; 50 | 0.0648 |
| SECONDARY Time to First Red Blood Cell (RBC) Transfusions |
— | — |
| SECONDARY Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA) |
0.4; 0.2; 0.5 | 0.61 |
| SECONDARY Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study |
6.0; 3.5; 5.4 | 0.62 |
| SECONDARY Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study |
-1.1; -1.1; -1.6 | 0.19 |
| SECONDARY Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study |
8.1; 8.9; 9.5 | 0.73 |
| SECONDARY C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16 |
24.8; 25.4; 31.6; 28.6; 16.6; 27.0 | 0.3852 |
| SECONDARY Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16 |
3.9; 4.0; 4.5; 6.1; 6.2; 7.1 | 0.1826 |
| SECONDARY Ferritin Level at Baseline, Week 7 and Week 16 |
460.5; 479.5; 456.0; 699.1; 420.6; 478.4 | 0.9022 |
| SECONDARY Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16 |
90.0; 88.5; 90.1; 93.0; 92.3; 92.8 | 0.1137 |
| SECONDARY Transferrin Saturation at Baseline, Week 7 and Week 16 |
22.5; 19.6; 22.2; 25.6; 26.4; 21.2 | 0.1139 |
Summary
RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy.
PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with iron to see how well it works compared with giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy in patients with cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of a non-myeloid cancer (other than non-melanomatous skin cancer)
- Receiving or scheduled to receive chemotherapy (biological agents, such as small molecules/tyrosine kinase inhibitors and antibody-based therapies, are allowed)
- Has chemotherapy-related anemia (hemoglobin 100 fL
- No anemia secondary to chemotherapy-induced myelodysplastic syndromes
- No primary hematologic disorder causing moderate to severe anemia (e.g., congenital dyserythropoietic anemia, homozygous hemoglobin S disease or compound heterozygous sickling states, or thalassemia major)
- Carriers for these disease states are eligible
- No first-degree relative with primary hemochromatosis (unless the patient has undergone HFE genotyping and was found to have at least one wild-type allele, while the proband in the family demonstrated to have either the common C282Y or H63D mutation)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Ferritin > 20 mcg/L (i.e., not obviously iron deficient)
- ALT or AST 100 cm of small intestine
- Not planning to undergo stem cell or bone marrow transplantation within the next 6 months
Data sourced from ClinicalTrials.gov (NCT00661999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.