Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Recombinant human erythropoietin · 1 trial · 1 indication
Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose for lenalidomide after a single dose, calculated using the log-linear trapezoidal method.
Area under the plasma concentration-time curve from Time 0 to 5 hours postdose for lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days, calculated using the log-linear trapezoidal method.
| Arm | Type | Description |
|---|---|---|
| 10 mg Lenalidomide | EXPERIMENTAL | Participants in the Pharmacokinetic Phase received a single 10 mg oral dose of lenalidomide on Day -7. During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure. During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment. |
| 15 mg Lenalidomide Non-del 5q | EXPERIMENTAL | Following the enrollment of the first 25 patients into the Monotherapy Phase, a second group of 15 patients with low- or intermediate-1-risk MDS not associated with a del 5q (non-del 5q) cytogenetic abnormality were enrolled to receive 15 mg of lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure. During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment. |
| Name | Type | Description |
|---|---|---|
| Lenalidomide | DRUG | Lenalidomide 5-mg capsules for oral administration |
| Recombinant human erythropoietin | DRUG | Recombinant human erythropoietin (rhu-EPO) subcutaneous injection of 40,000 units. |
Inclusion Criteria: 1. Must understand and voluntarily sign an informed consent form. 2. Age ≥18 years at the time of signing the informed consent form. 3. Must be able to adhere to the study visit schedule and other protocol requirements. 4. Documented diagnosis of MDS that meets International Pro...
Recombinant human erythropoietin is being studied for the treatment of Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS), a group of bone marrow disorders. It is currently in Phase 1 clinical development for this indication.
Recombinant human erythropoietin is being developed by Bristol-Myers Squibb Company, which is publicly traded under the ticker symbol BMY on the New York Stock Exchange.
Recombinant human erythropoietin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the treatment of Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS).
Recombinant human erythropoietin has one completed Phase 1 trial, NCT00910858, which studied its pharmacokinetics and pharmacodynamics in subjects with Low- or Intermediate-1-risk Myelodysplastic Syndromes. The trial enrolled 40 participants in the United States.
Recombinant human erythropoietin is not the same as lenalidomide. The clinical trial NCT00910858 studied oral lenalidomide (Revlimid) in subjects with Low- or Intermediate-1-risk Myelodysplastic Syndromes, but the drug being developed by Bristol-Myers Squibb is recombinant human erythropoietin.