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NCT02204553
Expanded Treatment Prot of Panobinostat in Combo w/ Bortez and Dex in Pts w/ Relapsed and/or Refractory Multiple Myeloma
trial testing Panobinostat in Multiple Myeloma. No longer available.
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Status | NO LONGER AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 27 locations across United States |
Drugs / interventions tested
- Panobinostat (PANOBINOSTAT) — full drug profile →
Conditions studied
- Multiple Myeloma — all drugs for Multiple Myeloma →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This will be a multi-center, open label, expanded treatment protocol of panobinostat, bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma. Panobinostat will be administered at a starting dose of 20mg orally three times a week (every other day) for two weeks on and one week off, with dose adjustments permitted based on observed toxicity. Bortezomib will be administered either intravenously or sub-cutaneously, twice a week on days 1 and 4, two weeks on 1 week off. After 8 cycles of treatment, patients who have achieved stable disease or better by modified EBMT 1998 criteria may continue combination therapy with bortezomib dosing changed to days 1 and 8 of a 21 day cycle for up to 48 weeks of therapy. At the end of the treatment period, (48 weeks) patients with stable disease or better may continue on therapy at the discretion of their investigator until September 2015 or until drug is commercially available, whichever comes first. Patients who have not achieved at least stable disease by 8 cycles must discontinue from study treatment. Dexamethasone will be administered on the day of and the day immediately following bortezomib treatment. Patients will not receive any study treatment during the third week of each cycle. Cycles will be defined as 21 days of treatment. Investigators may not add any other anti-myeloma agents (with the exception of bisphosphonates) while patients remain on study treatment. Patients will remain on study until disease progression, unacceptable toxicity, or end of the study
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02204553
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Panobinostat
Trials testing the same drug.
- NCT05725200 — Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer · Phase 2 · recruiting
- NCT04341311 — Phase I Study of Marizomib + Panobinostat for Children With DIPG · Phase 1 · terminated
- NCT03878524 — Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial · Phase 1 · terminated
- NCT04897880 — A Study of Panobinostat in Pediatric Patients With Solid Tumors Including MRT/ATRT · Phase 2 · terminated
- NCT04326764 — Panobinostat Maintenance After HSCT fo High-risk AML and MDS · Phase 3 · terminated
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
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet 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 NCT02204553 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 5 January 2016
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/NCT02204553.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing