Clinical trial · Interventional
Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma
Pilot Study of Lenalidomide and Dexamethasone in Combination With MEDI-551 in Previously Untreated Multiple Myeloma.
NCT01861340CI-TRIAL-00034761completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study is being done to see if combining the investigational chemotherapy drug, MEDI-551 with the known anti-myeloma drugs, Lenalidomide and Dexamethasone will reduce your myeloma cancer stem cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide, Dexamethasone, and MEDI-551 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide, Dexamethasone, and MEDI-551
- description
- Eligible patients will receive Lenalidomide and dexamethasone as per standard of care guidelines for 2 cycles. Patients with a clinical response to lenalidomide and dexamethasone after 2 cycles will proceed to get MEDI-551 for 2 cycles. MEDI-551 will be dosed at 4mg/kg IV on days 1 and 8 of cycle 3 and 4mg/kg IV on day 1 of cycle 4.
- interventionNames
- Drug: Lenalidomide, Dexamethasone, and MEDI-551
Primary outcomes (1)
- measure
- The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs).
- timeFrame
- 16 weeks
Secondary outcomes (1)
- measure
- The safety of Medi-551 when combined with Lenalidomide and dexamethasone.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 to 100 years at the time screening * Symptomatic, previously untreated (with exception of corticosteroids) secretory myeloma * Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations * Patient must agree to take Lenalidomide with low dose dexamethasone as their initial therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Life expectancy of \>6 months * Serum creatinine ≤ 2 * ANC≥1000 * Platelets ≥ 50,000 * Total bilirubin ≤ 2 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x ULN * Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin) Exclusion Criteria: * Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of patient safety or study results. * Concurrent enrollment in another clinical study, except for non-interventional, observational studies. * Any chemotherapy, immunotherapy, biologic, investigational, for treatment of multiple myeloma other than Lenalidomide and dexamethasone. * Previous monoclonal antibody (mAb) or other treatment specifically directed against cluster of differentiation antigen 19 (CD19). * History of serious allergy or reaction to any component of the MEDI-551 formulation that would prevent administration. * Previous systemic cancer therapy for myeloma. * Any active secondary malignancy. * Human immunodeficiency virus (HIV) positive serology or acquired immune deficiency syndrome. * Active hepatitis B as defined by seropositivity for hepatitis B surface antigen. Or patients with positive hepatitis B core antibody titers. * Patients with hepatitis C antibody will be eligible provided that they do not have elevated liver transaminases or other evidence of active hepatitis. * Documented current central nervous system involvement by multiple myeloma. * Previous medical history or evidence of an intercurrent illness that may, in the opinion of the investigator, compromise the safety of the patient in the study. * Diagnosis of plasma cell leukemia * Diagnosis of POEMS syndrome * Diagnosis of Amyloidosis * Diagnosis of non-secretory myeloma
References
Publications (0)
Data not yet available
No reference posted for this study.