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Lenalidomide and Prednisone in Low and Int-1 Myelodysplastic Syndrome (MDS) Non 5q MDS
Phase 2 trial testing Prednisone in Myelodysplastic Syndrome in 28 participants. Completed in 21 November 2019.
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 28 April 2010 |
| Primary completion | 31 January 2015 |
| Estimated completion | 21 November 2019 |
| Sites | 2 locations across United States |
H. Lee Moffitt Cancer Center and Research Institute
18 and older, any sex, with Myelodysplastic Syndrome or MDS. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The rate of erythroid response to treatment with the lenalidomide/prednisone combination in non-del (5q) low and int-1 risk Myelodysplastic Syndrome (MDS) with symptomatic anemia. Hematological improvement erythroid response (HI-E) according to International Working Group (IWG) 2006 criteria.
| Group | Value | 95% CI |
|---|---|---|
| Lenalidomide and Prednisone Therapy | 5 |
Grade 3 or 4 events Related/Possibly Related/Probably Related to study treatment. Number of participants with events specified in the study protocol: Neutropenia, Thrombocytopenia, Febrile Neutropenia, Infection, Sepsis, Venous Thromboembolic Events. Evaluations according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.0.
| Group | Value | 95% CI |
|---|---|---|
| Lenalidomide and Prednisone Therapy | 8 |
| Group | Value | 95% CI |
|---|---|---|
| Lenalidomide and Prednisone Therapy | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Lenalidomide and Prednisone Therapy | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Lenalidomide and Prednisone Therapy | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Lenalidomide and Prednisone Therapy | 0 |
Time frame: 4 years, 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lenalidomide and Prednison… |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Blood clot | Blood and lymphatic system disorders | — |
| Myocardial infarction | Cardiac disorders | — |
| Chest pain | Cardiac disorders | — |
| Heart arrhythmia | Cardiac disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Rectal bleeding | Gastrointestinal disorders | — |
| Severe abdominal cramping | Gastrointestinal disorders | — |
| Severe nausea | Gastrointestinal disorders | — |
| Uncontrolled vomiting | Gastrointestinal disorders | — |
| Small intestinal blockage | Gastrointestinal disorders | — |
| Edema limbs | General disorders | — |
| Sudden death NOS | General disorders | — |
| Fever | General disorders | — |
| Pain - sore throat | General disorders | — |
| Soft tissue infection | Infections and infestations | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Stroke / Cerebrovascular Accident (CVA) | Nervous system disorders | — |
| Confusion | Psychiatric disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Lenalidomide and Prednison… |
|---|---|---|
| Platelet count decreased | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Neutrophil count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Edema limbs | General disorders | — |
| Paul | General disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Movements involuntary | Nervous system disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Bruising | Injury, poisoning and procedural complications | — |
| Insomnia | Psychiatric disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Fever | General disorders | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Chills | General disorders | — |
| Dizziness | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Blurred vision | Eye disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Dry mouth | Gastrointestinal disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Creatinine increased | Investigations | — |
| Investigations - Other | Investigations | — |
Most-reported serious reactions: Anemia, Blood clot, Myocardial infarction, Chest pain, Heart arrhythmia, Diarrhea, Rectal bleeding, Severe abdominal cramping.
Data from ClinicalTrials.gov NCT01133275 adverse events section.
The purpose of this research is to evaluate the use of lenalidomide and prednisone in people with Myelodysplastic Syndrome (MDS). Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the U.S. Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for people with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. As it is being used in this study it is considered an investigational use. An "investigational use" is a use that is being tested and is not approved by the FDA. Prednisone is approved by the FDA to treat numerous conditions. In addition, prednisone is approved by the FDA to treat Low or Intermediate-1 IPSS Risk, non-del (5q) MDS. "Study drug" refers to the combination of lenalidomide and prednisone.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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