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| ID | Type | Description | Link |
|---|---|---|---|
| RV-AMYL-PI-0219 | Other Grant/Funding Number | Celgene | |
| BUMC-H-26320 | Other Identifier | Boston University Medical Center IRB |
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RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop the abnormal plasma cells from growing. Giving melphalan together with lenalidomide and dexamethasone may be an effective treatment for primary systemic amyloidosis.
PURPOSE: This phase II trial is studying the side effects and how well giving melphalan together with lenalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21, oral melphalan once daily on days 1-4, and oral dexamethasone once on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months until disease progression and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melphalan Revlimid and Dexamethasone | Experimental | Melphalan Lenalidomide Dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone | Drug | 40 mg once weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hematologic Response | Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Organs Improved or Stable Based on Description Below: | Renal response - > 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency. Hepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline. Cardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness > 11 mm or a decrease in New York Heart Association heart failure class. Autonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus. Gastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid. Peripheral nervous system response - resolution of clinical signs of peripheral neuropathy. |
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Inclusion Criteria:
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Recovered from prior therapy
Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed
More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or radiotherapy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vaishali Sanchorawala, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23144200 | Derived | Sanchorawala V, Patel JM, Sloan JM, Shelton AC, Zeldis JB, Seldin DC. Melphalan, lenalidomide and dexamethasone for the treatment of immunoglobulin light chain amyloidosis: results of a phase II trial. Haematologica. 2013 May;98(5):789-92. doi: 10.3324/haematol.2012.075192. Epub 2012 Nov 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Melphalan Revlimid and Dexamethasone | Melphalan Lenalidomide Dexamethasone dexamethasone: 40 mg once weekly lenalidomide: 10 mg/day Days 1-21 melphalan: 5 mg/m2 Days 1-4 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Melphalan Revlimid and Dexamethasone | Melphalan Lenalidomide Dexamethasone dexamethasone: 40 mg once weekly lenalidomide: 10 mg/day Days 1-21 melphalan: 5 mg/m2 Days 1-4 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Hematologic Response | Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more. | Participants who completed at least 3 cycles of treatment | Posted | Number | participants | one year |
|
1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Melphalan Revlimid and Dexamethasone | Melphalan Lenalidomide Dexamethasone dexamethasone: 40 mg once weekly lenalidomide: 10 mg/day Days 1-21 melphalan: 5 mg/m2 Days 1-4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| thromboembolism | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal bloating | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vaishali Sanchorawala | Boston Medical Center | 617-638-8265 | vaishali.sanchorawala@bmc.org |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D000077269 | Lenalidomide |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| lenalidomide | Drug | 10 mg/day D1-21 |
|
|
| melphalan | Drug | 5 mg/m2 D1-4 |
|
|
| one year |
| Number of Participants Removed From Study Due to Toxicities | Number of study participants removed from study treatment due to toxicities | One year |
| Withdrawal by Subject |
|
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 |
| Melphalan Revlimid and Dexamethasone |
Melphalan Lenalidomide Dexamethasone dexamethasone: 40 mg once weekly lenalidomide: 10 mg/day Days 1-21 melphalan: 5 mg/m2 Days 1-4 |
|
|
| Secondary | Number of Organs Improved or Stable Based on Description Below: | Renal response - > 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency. Hepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline. Cardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness > 11 mm or a decrease in New York Heart Association heart failure class. Autonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus. Gastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid. Peripheral nervous system response - resolution of clinical signs of peripheral neuropathy. | Posted | Number | number of organs stable or improved | one year | involved organs | involved organs |
|
|
|
| Secondary | Number of Participants Removed From Study Due to Toxicities | Number of study participants removed from study treatment due to toxicities | All patients who have had at least one dose of drug. | Posted | Count of Participants | Participants | One year |
|
|
|
| 16 |
| 16 |
| 16 |
| 16 |
| renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| heart failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| pleural effusion - bilateral | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Elevated blood urea nitrogen test | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| chest pressure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| gout pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| septic shock | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| tear duct obstruction/infection | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| increased creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| gastrointestinal bleed | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| hyponatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hyperglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| pancytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| abdominal cramping | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| altered taste | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| arthritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| aspiration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| blurring | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| cold intolerance | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| congestive heart failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| decreased bilirubin | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| decreased iron | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| decreased performance status | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| decreased renal function | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dysuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| early satiety | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| flatus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| gout | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| hearing loss | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| double vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| hemorrhoida | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| hip fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| hyperglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hyperkalemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hypermagnesemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hypernatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hyperphosphatemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hyperthyroidism | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| hyperuricemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hypoalbuminemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hypocalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hypokalemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hypomagnesemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hyponatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hypotension | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| increased alkaline phosphatate | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| increased Brain natriuretic peptide | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| increased creatinine | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| itchy eyes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| joint pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| leukocytosis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| mental disturbance | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| mouth sores | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | mucosal bleeding |
|
| muscle cramping | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| peripheral neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| nocturia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| pancytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| polydipsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| pruritis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | rectal bleed |
|
| rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| sciatica | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| stiffness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| sweats | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | tooth abscess |
|
| tremors | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| unsteady gait | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| infection - upper respiratory | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| infection - urinary tract | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| weakness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| weight loss | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |