An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

Conditions

• Hodgkin Lymphoma
• Multiple Myeloma
• Non-Hodgkin's Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — BIOLOGICAL
  Administered by intravenous (IV) infusion
• Ipilimumab — BIOLOGICAL
  Administered by IV infusion
• Lirilumab — BIOLOGICAL
  Administered by IV infusion
• Daratumumab — BIOLOGICAL
  Administered by IV infusion
• Pomalidomide — DRUG
  Administered PO
• Dexamethasone — DRUG
  Administered PO and by IV infusion

Study Details

The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.

Key Dates

Start date

Aug 2, 2012

Status verified

Oct 2025

Primary completion

Sep 25, 2020

Completion

Jul 9, 2024

Study Design

Enrollment

320 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nivolumab monotherapy (Dose Escalation)
  Nivolumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort
• Experimental: Nivolumab + Ipilimumab
  Nivolumab and Ipilimumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort
• Experimental: Nivolumab + Lirilumab
  Non-randomized Nivolumab: 3 mg/kg given every 2 weeks Lirilumab: 3 mg/kg given every 4 weeks Enrollment is closed for this cohort
• Experimental: Nivo + Dara + Pom + Dexa vs. Nivo + Dara
  Randomized Nivolumab: Cycle 1: 240 mg Day 15 Cycle 2-6: 240 mg Days 1, 15 Cycle 7 \& beyond: 480 mg Day 1 Daratumumab: Cycle 1-2: 16 mg/kg Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg Days 1, 15 Cycle 7 \& beyond: 16 mg/kg Day 1 Pomalidomide: 4 mg po (by mouth) daily on Days 1 - 21 of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing: * 40 mg po daily (Days 1, 8, 15, 22) of each 28-day cycle for participants ≤ 75 years old * 20 mg po daily (Days 1, 8, 15, 22) of each 28-day cycle for participants \> 75 years old Weeks with daratumumab dosing: * 20 mg iv before the daratumumab infusion and 20 mg po after the daratumumab infusion in participants ≤ 75 years old * 16 mg iv before the daratumumab infusion and 4 mg po after the daratumumab infusion in participants \> 75 years old Enrollment is closed for this cohort
• Experimental: Daratumumab vs. Nivolumab + Daratumumab
  Randomized Nivolumab: Cycle 1: 240 mg Day 15 Cycle 2 \& beyond: 480 mg Day 1 Daratumumab: Cycle 1-2: 16 mg/kg Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg Days 1, 15 Cycle 7 \& beyond: 16 mg/kg Day 1

Primary Outcome Measure

Number of Participants That Experienced Drug Related Grade 3-4 AEs [ Time Frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month ]

Locations (32)

Find similar trials in Clovis, CA

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