A Study of Durvalumab in Combination With Lenalidomide With and Without Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  single use vials administered via intravenous infusion
• Lenalidomide — DRUG
  capsules for oral administration
• Dexamethasone — DRUG
  tablets for oral administration

Study Details

This is a multicenter, open-label, Phase 1/2 study to determine the recommended dose and regimen of durvalumab in combination with lenalidomide (LEN) with and without dexamethasone (dex) in adults with newly diagnosed multiple myeloma (NDMM). The study will consist of a dose-finding phase as well as a parallel dose-expansion phase to determine the optimal regimen. \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\* The study was placed on full clinical hold by the United States (US) Food and Drug Administration (FDA) on 05 Sep 2017. The decision by the FDA was based on data from non-Celgene-sponsored studies related to risks of anti-programmed cell death 1 (PD-1), pembrolizumab, in combination with immunomodulatory agents. As the result, the study was closed for further enrollment, and all subjects were discontinued from all study treatments (durvalumab, lenalidomide and dexamethasone). All subjects are being followed for second primary malignancies (SPMs), every 6 months for 5 years after the last subject has been enrolled as per protocol. After stopping data collection in the clinical database, any SPM events will continue to be recorded in the subject's source documents, and reported to Celgene Drug Safety.

Key Dates

Start date

Apr 25, 2016

Status verified

Sep 2023

Primary completion

Dec 15, 2017

Completion

Sep 6, 2022

Study Design

Enrollment

56 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A: High risk, TNE
  High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered * Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle * Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\]) value on Days 1 to 21 of each 28-day treatment cycle * Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle
• Experimental: Cohort B: >=65 years old, TNE
  \>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered * Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle * Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\]) value on Days 1 to 21 of each 28-day treatment cycle * Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles
• Experimental: Cohort C: High risk, Post-transplant
  High risk, post-transplant NDMM participants were administered the following as maintenance therapy: * Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle * Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle

Primary Outcome Measure

Participants With Dose-Limiting Toxicities (DLTs) During the Dose-Determining Timeframe (Day 1 - Day 28) [ Time Frame: First treatment cycle: Day 1 to Day 28 ]

Locations (7)

Find similar trials in Birmingham, AL

Related Studies

• Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
• Collection of Samples and Clinical Data From Patients With Amyloid Diseases
  Recruiting · Boston Medical Center · Boston, Massachusetts
• Collection of Tissue Samples for Cancer Research
  Recruiting · National Cancer Institute (NCI) · Sacramento, California
• Integrated Cancer Repository for Cancer Research
  Recruiting · University of Nebraska · Greenwood Village, Colorado