Proportion of Patients Who Achieve a Confirmed Complete Response (CR)
Primary
· 2 years
| Group | Value | 95% CI |
|---|---|---|
| Cohort A | 0.32 | 0.184 – 0.474 |
| Cohort B | 0.30 | 0.175 – 0.475 |
Last reviewed · How we verify
NCT03012880
Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab in Treating Patients With Newly Diagnosed Multiple Myeloma
Completed
Phase 2
Results posted
Last updated 4 June 2025
What this trial tests
Phase 2 trial testing Daratumumab in Plasma Cell Myeloma in 80 participants. Completed in 15 December 2022.
Timeline
20 April 2017
Primary endpoint
15 December 2022
15 December 2022
15 December 2022
Quick facts
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 20 April 2017 |
| Primary completion | 15 December 2022 |
| Estimated completion | 15 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Daratumumab (daratumumab) — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
- Ixazomib Citrate
- Laboratory Biomarker Analysis — full drug profile →
- Lenalidomide — full drug profile →
- Questionnaire Administration
Conditions studied
- Plasma Cell Myeloma — all drugs for Plasma Cell Myeloma →
Sponsor
Mayo Clinic
Who can join
18 and older, any sex, with 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.
Proportion of Patients That Experienced a Grade 3 or Higher Adverse Event.
Secondary
· 2 years
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables are in the adverse event section of this report. The rate of patients that suffered a grade 3 or higher adverse event are reported here.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A | 0.58 | |
| Cohort B | 0.53 |
Overall Response Rate (ORR)
Secondary
· 2 years
Will be estimated by the number of patients who achieve a stringent complete response (sCR), CR, VGPR or partial response (PR) divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportions will be calculated.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A | 0.97 | 0.87 – 1.00 |
| Cohort B | 0.95 | 0.83 – 1.00 |
Overall Survival (OS)
Secondary
· 2 years
The distribution of overall survival will be estimated using the method of Kaplan-Meier.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A | NA | NA – NA |
| Cohort B | NA | NA – NA |
Progression Free Survival
Secondary
· 2 years
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A | NA | NA – NA |
| Cohort B | NA | NA – NA |
Rate of >= Very Good Partial Response (VGPR)
Secondary
· 2 years
Will be estimated by the number of patients with a VGPR, CR, or Stringent Complete Response (sCR) divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportions will be calculated.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A | 0.74 | 0.58 – 0.87 |
| Cohort B | 0.68 | 0.50 – 0.83 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A
Serious: 10/39 (26%)
Deaths: 4/39
Cohort B
Serious: 8/40 (20%)
Deaths: 1/40
Serious adverse events (28 terms)
| Reaction | System | Cohort A | Cohort B |
|---|---|---|---|
| Urinary tract infection | Infections and infestations | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Glaucoma | Eye disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Ileus | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Fever | General disorders | — | — |
| Flu like symptoms | General disorders | — | — |
| Multi-organ failure | General disorders | — | — |
| Appendicitis | Infections and infestations | — | — |
| Infections and infestations - Oth spec | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Upper respiratory infection | Infections and infestations | — | — |
| Creatinine increased | Investigations | — | — |
| Urine output decreased | Investigations | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Somnolence | Nervous system disorders | — | — |
| Confusion | Psychiatric disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
Other adverse events (57 terms — click to expand)
| Reaction | System | Cohort A | Cohort B |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Upper respiratory infection | Infections and infestations | — | — |
| Creatinine increased | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Peripheral motor neuropathy | Nervous system disorders | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Infections and infestations - Oth spec | Infections and infestations | — | — |
| Sinusitis | Infections and infestations | — | — |
| Lymphocyte count increased | Investigations | — | — |
| Edema limbs | General disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Blurred vision | Eye disorders | — | — |
| Pain | General disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Fracture | Injury, poisoning and procedural complications | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Neoplasms benign, mal, uncpec - Oth spec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Erectile dysfunction | Reproductive system and breast disorders | — | — |
| Resp, thoracic, mediastinal - Oth spec | Respiratory, thoracic and mediastinal disorders | — | — |
| Lymph node pain | Blood and lymphatic system disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Cataract | Eye disorders | — | — |
| Eye disorders - Other, specify | Eye disorders | — | — |
| Dental caries | Gastrointestinal disorders | — | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — | — |
| Gastrointestinal disorders - Oth spec | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Urinary tract infection, Atrial fibrillation, Lung infection, Dehydration, Syncope, Rash maculo-papular, Anemia, Glaucoma.
Data from ClinicalTrials.gov NCT03012880 adverse events section.
Sponsor's own description
This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, 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 daratumumab, may block cancer growth in different ways by targeting certain cells. Giving ixazomib citrate, lenalidomide, dexamethasone, and daratumumab may work better in treating patients with newly diagnosed multiple myeloma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Update on the role of lenalidomide in patients with multiple myeloma.
Holstein SA, Suman VJ, McCarthy PL. · · 2018 · cited 39× · PMID 30013765 · DOI 10.1177/2040620718775629 -
Daratumumab in untreated newly diagnosed multiple myeloma.
Abdallah N, Kumar SK. · · 2019 · cited 36× · PMID 31903177 · DOI 10.1177/2040620719894871 -
CD38 as Immunotherapeutic Target in Light Chain Amyloidosis and Multiple Myeloma-Association With Molecular Entities, Risk, Survival, and Mechanisms of Upfront Resistance.
Seckinger A, Hillengass J, Emde M, Beck S, et al · · 2018 · cited 32× · PMID 30079070 · DOI 10.3389/fimmu.2018.01676 -
The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of multiple myeloma.
Shah N, Aiello J, Avigan DE, Berdeja JG, et al · · 2020 · cited 29× · PMID 32661116 · DOI 10.1136/jitc-2020-000734 -
Immunotherapy in Multiple Myeloma.
Soekojo CY, Ooi M, de Mel S, Chng WJ. · · 2020 · cited 28× · PMID 32138182 · DOI 10.3390/cells9030601 -
The role of high-dose melphalan with autologous stem-cell transplant in multiple myeloma: is it time for a paradigm shift?
Kazandjian D, Mo CC, Landgren O, Richardson PG. · · 2020 · cited 25× · PMID 32501533 · DOI 10.1111/bjh.16764 -
Should Overall Survival Remain an Endpoint for Multiple Myeloma Trials?
Holstein SA, Suman VJ, McCarthy PL. · · 2019 · cited 17× · PMID 30661162 · DOI 10.1007/s11899-019-0495-9 -
Landscape of adenosine pathway and immune checkpoint dual blockade in NSCLC: progress in basic research and clinical application.
Wang R, Liu Z, Wang T, Zhang J, et al · · 2024 · cited 7× · PMID 38348050 · DOI 10.3389/fimmu.2024.1320244
Verify or expand the search:
- PubMed search for NCT03012880
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03012880 (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 Mayo Clinic
- Last refreshed: 4 June 2025
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/NCT03012880.
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