A Phase II Trial If Nivolumab, Lenalidomide and Dexamethasone in High Risk Smoldering Myeloma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT02903381
Phase
PHASE2
Status
Completed

Conditions

  • Smoldering Multiple Myeloma

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Intravenous, predetermined dosage, Days 1 and 15 during cycles 1-12 and
  • Lenalidomide — DRUG
    Oral, predetermined dosage, Days 1-21 of cycle 1-12
  • Dexamethasone — DRUG
    Oral, Days 1, 8, 15 of cycle 1-6

Study Details

This research study is evaluating a new drug called "nivolumab" as a possible treatment for smoldering multiple myeloma in order to prevent or postpone development of active multiple myeloma. \- Patients with smoldering multiple myeloma do not have symptoms but are at risk for progressing to active multiple myeloma. Multiple myeloma is a cancer of the plasma cell, which is an important part of the immune system. Patients with active multiple myeloma generally require treatment.

Key Dates

Start date
Oct 20, 2016
Status verified
May 2023
Primary completion
Jun 28, 2018
Completion
Sep 16, 2021

Study Design

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

Arms

  • Experimental: Nivolumab, Lenalidomide, Dexamethasone
    * A treatment cycle is defined as 28 consecutive days. * Participants will receive 6 cycles of induction therapy followed by 6 cycles of maintenance therapy with lower doses of lenalidomide and no dexamethasone for a total of 12 months.

Primary Outcome Measure

2 Year Progression Free Percent [ Time Frame: 2 Year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MA

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