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

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03283046
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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.
  • Lenalidomide — DRUG
    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.
  • Dexamethasone — DRUG
    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
  • Ipilimumab — DRUG
    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).

Study Details

This study has 2 parts: a Dose Escalation Part and a Dose Expansion Part. The goal of the Dose Escalation Part of this clinical research study is to find the highest tolerable dose of nivolumab in combination with ipilimumab and the standard of care (lenalidomide and dexamethasone) that can be given to patients with multiple myeloma (MM). The goal of the Dose Expansion Part of this clinical research study is to continue to study the safety of the highest tolerable dose found in Phase 1 of the study.

Key Dates

Start date
Oct 31, 2017
Status verified
Sep 2017
Primary completion
Oct 31, 2020
Completion
Oct 31, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + Ipilimumab + Dexamethasone + Lenalidomide
    The first 4 study cycles are 21 days long, and all remaining cycles are 28 days long. On Day 1 of Cycles 1-4, Nivolumab by vein over 60 minutes. Thirty (30)minutes after Nivolumab, Ipilimumab given by vein over 90 minutes. On Days 1 and 15 of Cycles 5 and beyond, Nivolumab given by vein over 60 minutes. Lenalidomide tablets take by mouth on Days 1-14 of Cycles 1-4 and on Days 1-21 of Cycles 5 and beyond. Dexamethasone tablets taken by mouth on Days 1, 8, and 15 of Cycles 1-4, and on Days 1, 8, 15, and 22 of Cycles 5 and beyond. For participants who are eligible for autologous stem cell transplant, those who achieve at least a partial response after at least 4 cycles of initial therapy will be eligible for: EITHER Stem cell collection and storage OR Stem cell collection and autologous stem cell transplantation.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Nivolumab and Ipilimumab with Dexamethasone and Lenalidomide (NILd) in Participants with Newly Diagnosed Multiple Myeloma [ Time Frame: 28 days ]

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