18 and older, any sex, with Recurrent Plasma Cell Myeloma or Refractory 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.
MTD, Defined as the Highest Dose in Which =< 1/6 Patients Experience a Dose-limiting Toxicity, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03Primary· 28 days
Observed toxicities will be summarized, for all dose levels, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, serum concentration of the active leflunomide metabolite, probable association with the study treatment and reversibility or outcome.
Group
Value
95% CI
All Participants
60
Best Overall Response Rate: Proportion of Patients Reaching CR by IMWG CriteriaPrimary· From the start of treatment until disease progression/recurrence, assessed up to 48 months
Stringent complete response \[sCR\]/complete response \[CR\]/very good partial response \[VGPR\]/or partial response \[PR\]), assessed by International Myeloma Working Group (IMWG) criteria.
Group
Value
95% CI
Arm 1: 20 mg Leflunomide
3
Arm 2: 40 mg Leflunomide
3
Arm 3: 60 mg Leflunomide
3
Clinical Benefit Response Rate (sCR/CR/VGPR/Partial Response [PR]/Minimal Response [MR] or Stable Disease [SD]), Assessed by IMWG CriteriaSecondary· From the start of treatment until disease progression/recurrence, assessed up to 48 months
Clinical benefit response rate (sCR/CR/VGPR/partial response \[PR\]/minimal response \[MR\] or stable disease \[SD\]), assessed by International Myeloma Working Group (IMWG) criteria
Group
Value
95% CI
Arm 1: 20 mg Leflunomide
3
Arm 2: 40 mg Leflunomide
3
Arm 3: 60 mg Leflunomide
3
Response DurationSecondary· Assessed up to 48 months
Median and range of nine patients with Complete Response (CR)
Group
Value
95% CI
Arm 1: 20 mg Leflunomide
336
28 – 401
Arm 2: 40 mg Leflunomide
112
91 – 152
Arm 3: 60 mg Leflunomide
54
28 – 56
Response DurationSecondary· Assessed at ninety days.
Number of patients with Stable Disease greater than or equal to 90 days
Group
Value
95% CI
Arm 1: 20 mg Leflunomide
2
Arm 2: 40 mg Leflunomide
3
Arm 3: 60 mg Leflunomide
0
Adverse events — posted to ClinicalTrials.gov
Time frame: up to thirty days post-treatment..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase I/II trial studies the side effects and best dose of leflunomide in treating patients with multiple myeloma that has come back (relapsed) or has not responded to previous treatment (refractory). Leflunomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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
Other City of Hope Medical Center trials
Trials by the same sponsor.
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· Phase 2
· not yet recruiting
NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy
· Phase 2
· not yet recruiting
NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment
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NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o
· NA
· withdrawn
NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can
· NA
· not yet recruiting
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 City of Hope Medical Center
Last refreshed: 10 October 2023
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/NCT02509052.