NCT01861340
Completed
Early Phase 1
Pilot Study of Lenalidomide and Dexamethasone in Combination With MEDI-551 in Previously Untreated Multiple Myeloma.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 country20 target enrollmentStarted: May 2014Last updated:
ConditionsMyeloma
InterventionsLenalidomide, Dexamethasone, and MEDI-551
Overview
- Phase
- Early Phase 1
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs).
Overview
Brief Summary
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.
Detailed Description
To explore the effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs). Myeloma CSCs will be assessed by a clonogenic assay from the bone marrow and flow cytometry from peripheral blood.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Life expectancy of \>6 months
- •Serum creatinine ≤ 2
- •Platelets ≥ 50,000
- •Total bilirubin ≤ 2 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x ULN
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.
Arms & Interventions
Lenalidomide, Dexamethasone, and MEDI-551
Experimental
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.
Intervention: Lenalidomide, Dexamethasone, and MEDI-551 (Drug)
Outcomes
Primary Outcomes
The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs).
Time Frame: 16 weeks
Secondary Outcomes
- The safety of Medi-551 when combined with Lenalidomide and dexamethasone.(28 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 4
Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple MyelomaMultiple MyelomaNCT01731886Columbia University60
Completed
Phase 2
Study of Lenalidomide and Low-Dose Dexamethasone in Chinese Subjects With Relapsed/Refractory Multiple MyelomaMultiple MyelomaNCT01593410Celgene194
Completed
Phase 2
A Study of Low Dose Lenalidomide and Dexamethasone in Relapsed/Refractory Myeloma in Patients at High Risk for MyelosuppressionMultiple MyelomaNCT00482261Peter MacCallum Cancer Centre, Australia150
Completed
Phase 2
Lenalidomide and Dexamethasone in Primary Plasma Cell LeukemiaPrimary Plasma Cell LeukemiaNCT01553357IRCCS Centro di Riferimento Oncologico della Basilicata23
Terminated
Phase 3
Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185)Multiple MyelomaNCT02579863Merck Sharp & Dohme LLC310