NCT03267888

Pembrolizumab and Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma

Completed Phase 1, PHASE2 Results posted Last updated 4 September 2024

What this trial tests

Phase 1, PHASE2 trial testing Pembrolizumab in ISS Stage I Plasma Cell Myeloma in 25 participants. Completed in 2 September 2022.

Timeline

29 May 2018

Primary endpoint
2 September 2022

2 September 2022

Quick facts

Lead sponsor	Emory University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	29 May 2018
Primary completion	2 September 2022
Estimated completion	2 September 2022
Sites	1 location across United States

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Radiation Therapy — full drug profile →

Conditions studied

• ISS Stage I Plasma Cell Myeloma — all drugs for ISS Stage I Plasma Cell Myeloma →
• ISS Stage II Plasma Cell Myeloma — all drugs for ISS Stage II Plasma Cell Myeloma →
• ISS Stage III Plasma Cell Myeloma — all drugs for ISS Stage III Plasma Cell Myeloma →
• Recurrent Plasma Cell Myeloma — all drugs for Recurrent Plasma Cell Myeloma →

Sponsor

Emory University

Who can join

18 and older, any sex, with ISS Stage I Plasma Cell Myeloma or ISS Stage II Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · Up to 12 months after study start

Greater than grade 2 toxicity will be assessed by Common Terminology Criteria for Adverse Events.

Group	Value	95% CI
Radiation Therapy, Pembrolizumab	8

Number of Patients Achieving Any Response Secondary · Up to 12 months after study start

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR according to International Myeloma Working Group (IMWG) criteria.

Group	Value	95% CI
Radiation Therapy, Pembrolizumab	8

Number of Participants Who Showed an Overall Response to Treatment Based on Baseline Changes on Positron Emission to Positron Emission Tomography/Computed Tomography Secondary · Up to 12 months after study start

Will be defined using International IMWG criteria.

Group	Value	95% CI
Radiation Therapy, Pembrolizumab	20	7 – 41

Overall Survival Secondary · From first treatment on course 1, day 1 to the earlier of date of death and/or last follow up, assessed up to 12 months

Will be estimated using the Kaplan-Meier product-limit method.

Group	Value	95% CI
Radiation Therapy, Pembrolizumab	15

Adverse events — posted to ClinicalTrials.gov

Time frame: The first 12 months of treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Radiation Therapy, Pembrolizumab

Serious: 1/25 (4%)

Deaths: 10/25

Serious adverse events (1 terms)

Reaction	System	Radiation Therapy, Pembrol…
Fatigue	General disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	Radiation Therapy, Pembrol…
Fatigue	General disorders	—
Fever	Immune system disorders	—
Rigours during infusion	Musculoskeletal and connective tissue disorders	—
Hypothyroidism	Endocrine disorders	—

Most-reported serious reactions: Fatigue.

Data from ClinicalTrials.gov NCT03267888 adverse events section.

Sponsor's own description

This pilot clinical trial studies the side effects of pembrolizumab and radiation therapy in treating patients with stage I-III multiple myeloma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as pembrolizumab, may block cancer growth in different ways by targeting certain cells. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving pembrolizumab and radiation therapy may work better in treating patients with stage I-III multiple myeloma.

Publications & conference data

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

1. 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
2. Monoclonal Antibodies for the Treatment of Multiple Myeloma: An Update.
   Abramson HN. · · 2018 · cited 42× · PMID 30544512 · DOI 10.3390/ijms19123924
3. Immunotherapy of Multiple Myeloma: Current Status as Prologue to the Future.
   Abramson HN. · · 2023 · cited 16× · PMID 37958658 · DOI 10.3390/ijms242115674
4. Checkpoint inhibition in hematologic malignancies.
   Tsumura A, Levis D, Tuscano JM. · · 2023 · cited 14× · PMID 37920162 · DOI 10.3389/fonc.2023.1288172
5. Immunotherapy of Multiple Myeloma: Promise and Challenges.
   Abramson HN. · · 2021 · cited 12× · PMID 34527606 · DOI 10.2147/itt.s306103
6. Checkpoint Inhibitors in Multiple Myeloma: Intriguing Potential and Unfulfilled Promises.
   Alkharabsheh O, Trisel Z, Badami S, Aljama MA, et al · · 2021 · cited 8× · PMID 35008276 · DOI 10.3390/cancers14010113
7. Pembrolizumab and low-dose, single-fraction radiotherapy for patients with relapsed or refractory multiple myeloma: a prospective, single-centre, single-group, open-label, phase 2 pilot trial in the USA.
   Khan MK, Nasti TH, Qian JY, Kleber TJ, et al · · 2024 · cited 1× · PMID 38797190 · DOI 10.1016/s2352-3026(24)00105-4