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NCT03333746
Lenalidomide and Nivolumab in Treating Patients With Relapsed or Refractory Multiple Myeloma
Phase 2 trial testing Laboratory Biomarker Analysis in Recurrent Plasma Cell Myeloma in 1 participant. Terminated before completion.
13 August 2018
Quick facts
| Lead sponsor | Yvonne Efebera |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 21 March 2018 |
| Primary completion | 13 August 2018 |
| Estimated completion | 16 November 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Laboratory Biomarker Analysis
- Lenalidomide — full drug profile →
- Nivolumab (nivolumab) — full drug profile →
- Pharmacological Study — full drug profile →
Conditions studied
- Recurrent Plasma Cell Myeloma — all drugs for Recurrent Plasma Cell Myeloma →
- Refractory Plasma Cell Myeloma — all drugs for Refractory Plasma Cell Myeloma →
Sponsor
Yvonne Efebera
Who can join
18 and older, any sex, with Recurrent Plasma Cell Myeloma or Refractory Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected up to 8 months during the study was conducted.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other adverse events (27 terms — click to expand)
| Reaction | System | Treatment (Lenalidomide, N… |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Aspartate Aminotransferasae Increased | Investigations | — |
| Blood Bilirubin Increased | Investigations | — |
| Cognitive Disturbance | Nervous system disorders | — |
| Cough (non-productive) | Respiratory, thoracic and mediastinal disorders | — |
| Diarrhea-intermittent | Gastrointestinal disorders | — |
| Dry Skin- Bilateral Lower Extremities | Skin and subcutaneous tissue disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Eye Hemorrhage | Eye disorders | — |
| Fatigue | General disorders | — |
| Generlized Weakness | Musculoskeletal and connective tissue disorders | — |
| Hip Pain- Bilateral | General disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Insomnia | Psychiatric disorders | — |
| Localized Edema (Bilateral Ankles) | General disorders | — |
| Lymphocyte Count Decreased | Investigations | — |
| Myalgia- Left Rib | Musculoskeletal and connective tissue disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Neutrophil Count Decreased | Investigations | — |
| Platelet Count Decreased | Investigations | — |
| White Blood Cell Decreased | Investigations | — |
Data from ClinicalTrials.gov NCT03333746 adverse events section.
Sponsor's own description
This phase II trial studies how well lenalidomide and nivolumab work in treating patients with multiple myeloma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide and nivolumab may work better in treating patients with multiple myeloma.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Monoclonal Antibodies for the Treatment of Multiple Myeloma: An Update.
Abramson HN. · · 2018 · cited 42× · PMID 30544512 · DOI 10.3390/ijms19123924 -
Immune-based therapies in the management of multiple myeloma.
Zanwar S, Nandakumar B, Kumar S. · · 2020 · cited 41× · PMID 32829378 · DOI 10.1038/s41408-020-00350-x -
Deregulation of Adaptive T Cell Immunity in Multiple Myeloma: Insights Into Mechanisms and Therapeutic Opportunities.
Leblay N, Maity R, Hasan F, Neri P. · · 2020 · cited 36× · PMID 32432039 · DOI 10.3389/fonc.2020.00636 -
Immunotherapy: A Novel Era of Promising Treatments for Multiple Myeloma.
Castella M, Fernández de Larrea C, Martín-Antonio B. · · 2018 · cited 25× · PMID 30445802 · DOI 10.3390/ijms19113613
Verify or expand the search:
- PubMed search for NCT03333746
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Recurrent Plasma Cell Myeloma
Currently open trials in the same condition.
- NCT04756401 — Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple M · Phase 2 · active not recruiting
- NCT05363111 — Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma · Phase 1 · recruiting
- NCT05391750 — Venetoclax and Tocilizumab for the Treatment of Patients With Relapsed or Refractory t(11;14) Multiple Myeloma · Phase 1 · active not recruiting
- NCT05514990 — Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AM · Phase 1, PHASE2 · active not recruiting
- NCT05312255 — Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03333746 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yvonne Efebera
- Last refreshed: 30 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03333746.
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