NCT01754402 is a Phase 1, PHASE2 clinical trial of Bendamustine in Multiple Myeloma, sponsored by Cristina Gasparetto.

Who is sponsoring NCT01754402?

NCT01754402 is sponsored by Cristina Gasparetto.

What drugs are being tested in NCT01754402?

Interventions in NCT01754402: Bendamustine, Pomalidomide, Dexamethasone.

What condition does NCT01754402 study?

NCT01754402 studies Multiple Myeloma.

Is NCT01754402 still recruiting?

NCT01754402 is currently status unknown. Last updated 20 February 2024.

Are results published for NCT01754402?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-02-20 · How we verify

NCT01754402

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma

Status unknown Phase 1, PHASE2 Results posted Last updated 20 February 2024

What this trial tests

Phase 1, PHASE2 trial testing Bendamustine in Multiple Myeloma in 56 participants. Status unknown.

Timeline

7 January 2013

Primary endpoint
6 December 2016

1 January 2025

Quick facts

Lead sponsor	Cristina Gasparetto
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	7 January 2013
Primary completion	6 December 2016
Estimated completion	1 January 2025
Sites	1 location across United States

Drugs / interventions tested

Bendamustine (BENDAMUSTINE) — full drug profile →
Pomalidomide — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Cristina Gasparetto — full company profile →

Who can join

18 and older, any sex, with Multiple 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.

Maximum Tolerated Dose of Pomalidomide and Bendamustine Primary · 2 cycles (approximately 2 months)

In the phase I dose escalation portion, patients will be sequentially enrolled in 4 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) is reached. Cohort 1 (bendamustine 120mg/m2 + pomalidomide 3mg); Cohort 2 (bendamustine 120mg/m2 + pomalidomide 4mg); Cohort 3 (bendamustine 150mg/m2 + pomalidomide 4mg); Cohort 4 (bendamustine 180mg/m2 + pomalidomide 4mg) If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, th

Pomalidomide

Group	Value	95% CI
Cohorts 1 and 2	3

Bendamustine

Group	Value	95% CI
Cohorts 1 and 2	120

Initial Response Rate Primary · 2 cycles (approximately 2 months)

The number of patients achieving a complete response (CR) or partial response (PR). Response is defined by the International Myeloma Working Group as: CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \< 5% plasma cells in bone marrow PR- \> 50% reduction of serum M-protein and urine M-protein by \>90% or to \< 200 mg/24 h In addition, if present at baseline, a \> 50% reduction in the size of soft tissue plasmacytomas is also required VGPR - Serum and urine M-protein detectable by immunofixation but n

Partial Response

Group	Value	95% CI
Cohort 1: 120mg Bendamustine + 3mg Pomalidomide	1
Expansion: 120mg Bendamustine + 3mg Pomalidomide	11

Very Good Partial Response

Group	Value	95% CI
Cohort 1: 120mg Bendamustine + 3mg Pomalidomide	0
Expansion: 120mg Bendamustine + 3mg Pomalidomide	2

Complete Response

Group	Value	95% CI
Cohort 1: 120mg Bendamustine + 3mg Pomalidomide	0
Expansion: 120mg Bendamustine + 3mg Pomalidomide	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days past last day of drug, up to 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1: 120mg Bendamustine + 3mg Pomalidomide

Serious: 6/6 (100%)

Deaths: 6/6

Cohort 2: 120mg Bendamustine + 4mg Pomalidomide

Serious: 1/2 (50%)

Deaths: 2/2

Expansion: 120mg Bendamustine + 3mg Pomalidomide

Serious: 17/30 (57%)

Deaths: 13/30

Serious adverse events (33 terms)

Reaction	System	Cohort 1: 120mg Bendamusti…	Cohort 2: 120mg Bendamusti…	Expansion: 120mg Bendamust…
Fever	General disorders	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—
Lung infection	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Infections and infestations - Other, specify	Infections and infestations	—	—	—
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	—	—	—
Psychiatric disorders - Other, specify	Psychiatric disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Hypotension	Vascular disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Chest pain - cardiac	Cardiac disorders	—	—	—
Supraventricular tachycardia	Cardiac disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	—	—	—
Mucositis oral	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Death NOS	General disorders	—	—	—
Bronchial infection	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Fracture	Injury, poisoning and procedural complications	—	—	—
Postoperative hemorrhage	Injury, poisoning and procedural complications	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—

Other adverse events (121 terms — click to expand)

Reaction	System	Cohort 1: 120mg Bendamusti…	Cohort 2: 120mg Bendamusti…	Expansion: 120mg Bendamust…
Neutrophil count decreased	Investigations	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—
Fatigue	General disorders	—	—	—
Platelet count decreased	Investigations	—	—	—
White blood cell decreased	Investigations	—	—	—
Hypomagnesemia	Metabolism and nutrition disorders	—	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Metabolism and nutrition disorders - Other, specify	Metabolism and nutrition disorders	—	—	—
Musculoskeletal and connective tissue disorder - Other, specify	Musculoskeletal and connective tissue disorders	—	—	—
Lymphocyte count decreased	Investigations	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—
Creatinine increased	Investigations	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Hypophosphatemia	Metabolism and nutrition disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—
Fever	General disorders	—	—	—
Alkaline phosphatase increased	Investigations	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Edema limbs	General disorders	—	—	—
General disorders and administration site conditions - Other, specify	General disorders	—	—	—
Activated partial thromboplastin time prolonged	Investigations	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
INR increased	Investigations	—	—	—
Weight loss	Investigations	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Confusion	Psychiatric disorders	—	—	—

Most-reported serious reactions: Fever, Febrile neutropenia, Lung infection, Sepsis, Infections and infestations - Other, specify, Generalized muscle weakness, Psychiatric disorders - Other, specify, Cough.

Data from ClinicalTrials.gov NCT01754402 adverse events section.

Sponsor's own description

This study is designed as a phase I-II, open label, dose finding study. Study treatment will be as follows, in 28 day cycles: * Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenously (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22. After completing 6 cycles of treatment, dexamethasone may be decreased to 20mg per investigator discretion. After completing 12 cycles of treatment, patients will proceed to the maintenance phase of the study. Patients will receive Pomalidomide on day 1-21, every 28 days and dexamethasone on days 1, 8, 15, and 22 every 28 days until time of progression.

Publications & conference data

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

Pomalidomide: the new immunomodulatory agent for the treatment of multiple myeloma.
Chanan-Khan AA, Swaika A, Paulus A, Kumar SK, et al · · 2013 · cited 94× · PMID 24013664 · DOI 10.1038/bcj.2013.38
Ikaros Proteins in Tumor: Current Perspectives and New Developments.
Xia R, Cheng Y, Han X, Wei Y, et al · · 2021 · cited 12× · PMID 34950704 · DOI 10.3389/fmolb.2021.788440
Bendamustine, pomalidomide, and dexamethasone for relapsed and/or refractory multiple myeloma.
Sivaraj D, Green MM, Kang Y, Long GD, et al · · 2018 · cited 11× · PMID 30065277 · DOI 10.1038/s41408-018-0104-5
Clinical outcomes of pomalidomide-based and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma: A real-world cohort study in China.
Han X, Jiang X, He J, Zheng G, et al · · 2024 · cited 4× · PMID 38698679 · DOI 10.1002/cam4.7232

Verify or expand the search:

Other trials of Bendamustine

Trials testing the same drug.

NCT07225985 — Pralatrexate With Bendamustine and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Re · Phase 1, PHASE2 · not yet recruiting
NCT07189065 — A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma · Phase 2 · recruiting
NCT07169565 — Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia · Phase 1 · not yet recruiting
NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
NCT07003464 — Phase II Trial of Zanubrutinib, Obinutuzumab, Bendamustine (ZGB) as First-Line Therapy for Chronic Lymphocytic Leukemia: · Phase 2 · not yet recruiting

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting

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 NCT01754402 (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 Cristina Gasparetto
Last refreshed: 20 February 2024

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/NCT01754402.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing