NCT02616640

A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

Completed Phase 1 Last updated 19 September 2024

What this trial tests

Phase 1 trial testing Durvalumab in Multiple Myeloma in 114 participants. Completed in 30 July 2024.

Timeline

11 January 2016

Primary endpoint
23 November 2018

30 July 2024

Quick facts

Lead sponsor	Celgene
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	114
Start date	11 January 2016
Primary completion	23 November 2018
Estimated completion	30 July 2024
Sites	22 locations across France, Italy, Netherlands, Germany, Canada, United States, Spain

Drugs / interventions tested

• Durvalumab — full drug profile →
• Pomalidomide — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion portion to determine the optimal dose and regimen.

On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Checkpoint inhibitors in hematological malignancies.
   Ok CY, Young KH. · · 2017 · cited 93× · PMID 28482851 · DOI 10.1186/s13045-017-0474-3
2. Update on PD-1/PD-L1 Inhibitors in Multiple Myeloma.
   Jelinek T, Paiva B, Hajek R. · · 2018 · cited 82× · PMID 30505301 · DOI 10.3389/fimmu.2018.02431
3. Modulating PD-L1 expression in multiple myeloma: an alternative strategy to target the PD-1/PD-L1 pathway.
   Tremblay-LeMay R, Rastgoo N, Chang H. · · 2018 · cited 53× · PMID 29580288 · DOI 10.1186/s13045-018-0589-1
4. Checkpoint Inhibition in Myeloma: Opportunities and Challenges.
   Costa F, Das R, Kini Bailur J, Dhodapkar K, et al · · 2018 · cited 49× · PMID 30319648 · DOI 10.3389/fimmu.2018.02204
5. Immune checkpoint blockade for hematologic malignancies: a review.
   Pianko MJ, Liu Y, Bagchi S, Lesokhin AM. · · 2017 · cited 48× · PMID 28529947 · DOI 10.21037/sci.2017.03.04
6. Osteoclast Immunosuppressive Effects in Multiple Myeloma: Role of Programmed Cell Death Ligand 1.
   Tai YT, Cho SF, Anderson KC. · · 2018 · cited 47× · PMID 30147691 · DOI 10.3389/fimmu.2018.01822
7. Targeting NK Cell Inhibitory Receptors for Precision Multiple Myeloma Immunotherapy.
   Alfarra H, Weir J, Grieve S, Reiman T. · · 2020 · cited 44× · PMID 33304346 · DOI 10.3389/fimmu.2020.575609
8. Monoclonal Antibodies for the Treatment of Multiple Myeloma: An Update.
   Abramson HN. · · 2018 · cited 42× · PMID 30544512 · DOI 10.3390/ijms19123924