Study of Lenalidomide/Dexamethasone With Nivolumab and Ipilimumab in Patients With Newly Diagnosed Multiple Myeloma

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 31, 2017

Primary Completion Date

October 31, 2020

Study Completion Date

October 31, 2020

Conditions
Malignant Neoplasms Stated as Primary Lymphoid HaematopoieticMultiple Myeloma
Interventions
DRUG

Nivolumab

"Dose Escalation Phase Starting Dose: Nivolumab 1 mg/kg by vein over 60 minutes every 3 weeks for 4 doses, followed by Nivolumab 240 mg by vein every 2 weeks until disease progression or unacceptable toxicity on Days 1 and 15 each cycle.~Dose Expansion Phase Starting Dose: Maximum tolerated dose (MTD) from Dose Escalation Phase.~Maintenance: Nivolumab 240 mg by vein every 2 weeks until disease progression or unacceptable toxicity on Days 1 and 15 each cycle."

DRUG

Lenalidomide

"Dose Escalation and Dose Expansion Dose: Lenalidomide 25 mg by mouth on Days 1- 14 in 21 day cycles and Days 1-21 in 28 day cycles.~Maintenance: Lenalidomide 10 mg by mouth on Days 1-21."

DRUG

Dexamethasone

Dose Escalation and Dose Expansion Dose: Dexamethasone 40 mg by mouth on Days 1,8,15 in 21 day cycles and 1,8,15 and 22 in 28 day cycles

DRUG

Ipilimumab

"Dose Escalation and Dose Expansion Dose: Ipilimumab 1 mg/kg by vein over 90 minutes every 3 weeks for 4 doses.~Maintenance: If there is evidence of disease progression, Ipilimumab reintroduced at 3 mg/kg every 3 weeks for 4 doses. (Nivolumab dose in Combination determined by the phase 1 portion)."

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT03283046 - Study of Lenalidomide/Dexamethasone With Nivolumab and Ipilimumab in Patients With Newly Diagnosed Multiple Myeloma | Biotech Hunter | Biotech Hunter