Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer
Condition: Anemia; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Precancerous Conditions; Anemia; Lymphoproliferative Disorders
Intervention: darbepoetin alfa; ferrous sulfate; sodium ferric gluconate complex in sucrose; placebo
Intervention description: Given by injection; Given by mouth; Given by IV; Given by mouth
Intervention MeSH terms: Darbepoetin alfa; Ferric gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 502.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: unspecified adult solid tumor, protocol specific; monoclonal gammopathy of undetermined significance; extramedullary plasmacytoma; isolated plasmacytoma of bone; refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; primary systemic amyloidosis; Waldenstrom macroglobulinemia; post-transplant lymphoproliferative disorder; stage I adult T-cell leukemia/lymphoma; stage II adult T-cell leukemia/lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma; recurrent adult T-cell leukemia/lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma; stage I cutaneous T-cell non-Hodgkin lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; recurrent mycosis fungoides/Sezary syndrome; stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; recurrent adult Hodgkin lymphoma; recurrent adult grade III lymphomatoid granulomatosis; stage I adult Burkitt lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma; noncontiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II mantle cell lymphoma; noncontiguous stage II marginal zone lymphoma; noncontiguous stage II small lymphocytic lymphoma; contiguous stage II adult Burkitt lymphoma; contiguous stage II adult diffuse large cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult diffuse small cleaved cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; contiguous stage II adult lymphoblastic lymphoma; contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma; contiguous stage II mantle cell lymphoma; contiguous stage II marginal zone lymphoma; contiguous stage II small lymphocytic lymphoma; stage I adult diffuse large cell lymphoma; stage I adult diffuse mixed cell lymphoma; stage I adult diffuse small cleaved cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage I adult lymphoblastic lymphoma; stage III adult lymphoblastic lymphoma; stage IV adult lymphoblastic lymphoma; stage I grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; stage I grade 3 follicular lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage I mantle cell lymphoma; stage I marginal zone lymphoma; stage III mantle cell lymphoma; stage III marginal zone lymphoma; stage IV mantle cell lymphoma; stage IV marginal zone lymphoma; stage I small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage IV small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; recurrent adult Burkitt lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; adult acute lymphoblastic leukemia in remission; recurrent adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; refractory chronic lymphocytic leukemia; refractory hairy cell leukemia; progressive hairy cell leukemia, initial treatment; prolymphocytic leukemia; anemia; T-cell large granular lymphocyte leukemia; acute undifferentiated leukemia; mast cell leukemia; adult nasal type extranodal NK/T-cell lymphoma; untreated hairy cell leukemia

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 < 11 g/dL)

               -  No anemia known to be secondary to gastrointestinal bleeding or hemolysis

               -  No anemia known to be secondary to vitamin B12 or folic acid deficiency

                  + Vitamin B12 and folic acid deficiency must be ruled out if the mean corpuscular
                  volume (MCV) is > 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 < 5 times upper limit of normal

          -  Alert, mentally competent, and able to sign informed consent

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  Willing or able to be randomized and undergo study treatment

          -  Willing or able to fill out quality-of-life forms

          -  No uncontrolled hypertension (i.e., systolic blood pressure [BP] ≥ 180 mm Hg or
             diastolic BP ≥ 100 mm Hg)

          -  No history of uncontrolled cardiac arrhythmias

          -  No pulmonary embolism or deep venous thrombosis within the past year (unless the
             patient is on anticoagulation therapy and planning to continue it during study
             participation)

          -  No known hypersensitivity to darbepoetin alfa, erythropoietin, mammalian cell-derived
             products, iron, or human albumin

          -  No seizures within the past 3 months

          -  No gastrointestinal conditions expected to cause significant impairment of oral iron,
             such as untreated celiac disease or amyloidosis involving the gut - Patients with
             celiac disease who are adhering to a gluten-free diet are eligible

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 3 months since prior darbepoetin alfa, epoetin alfa, or any investigational
             forms of erythropoietin (e.g., gene-activated erythropoietin or novel
             erythropoiesis-stimulating protein)

          -  More than 1 year since prior peripheral blood stem cell or bone marrow transplantation

          -  More than 2 weeks since prior red blood cell transfusions

          -  More than 14 days since prior major surgery

          -  No prior gastrectomy or resection of > 100 cm of small intestine

          -  Not planning to undergo stem cell or bone marrow transplantation within the next 6
             months