An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dexamethasone — DRUG
  Dexamethasone, a corticosteroid, is similar to a natural hormone produced by adrenal glands. It relieves inflammation.
• Pomalidomide — DRUG
  Pomalidomide which is an immunomodulatory drug. This means that pomalidomide modulates the immune system to help fight diseases.
• Elotuzumab — DRUG
  Elotuzumab is an antibody, that stimulates the immune system to fight diseases
• Nivolumab — DRUG
  Nivolumab works by blocking an inhibitory signal within immune cells, potentially allowing the immune system to fight the cancer

Study Details

This research study is studying a combination of targeted therapies as a possible treatment for multiple myeloma (MM). The drugs involved in this study are: * Elotuzumab * Nivolumab * Pomalidomide * Dexamethasone

Key Dates

Start date

Dec 31, 2018

Status verified

Aug 2018

Primary completion

Dec 31, 2021

Completion

Dec 31, 2024

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nivolumab + Elotuzumab
  * 22 patients will be entered, If \> 4 patients achieve at least a partial response (PR) within 4 cycles an additional 18 patients will be treated. * Nivolumab will be administered intravenously twice per cycle for cycle 1-4 * Nivolumab will be administered intravenously once per cycle for cycle 5 * Elotuzumab will be administered intravenously 4 times per cycle for cycle 1-2 * Elotuzumab will be administered intravenously twice per cycle for cycle 3-4 * Elotuzumab will be administered intravenously once per cycle for cycle 5
• Experimental: Nivolumab+Elotuzumab+Pomalidomide+Dexamethasone
  * Nivolumab will be administered intravenously twice per cycle for cycle 1-4 * Nivolumab will be administered intravenously once per cycle for cycle 5 * Elotuzumab will be administered intravenously 4 times per cycle for cycle 1-2 * Elotuzumab will be administered intravenously twice per cycle for cycle 3-4 * Elotuzumab will be administered intravenously once per cycle for cycle 5 * Pomalidomide will be administered for 21 days per cycle * Dexamethasone will be administered weekly

Primary Outcome Measure

Response Rate [ Time Frame: 2 years ]

Locations (3)

Find similar trials in Boston, MA

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