Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02401295
Other study ID # 201311791
Secondary ID
Status Completed
Phase Phase 1
First received March 18, 2015
Last updated February 20, 2017
Start date May 2015
Est. completion date November 2016

Study information

Verified date February 2017
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability associated with the combination of ATRA/celecoxib/itraconazole as maintenance therapy given after an autologous stem cell transplant in relapsed multiple myeloma patients.


Description:

Primary objective:

To evaluate safety and tolerability associated with the combination of ATRA/ celecoxib/itraconazole given after a salvage transplant for relapsed myeloma in 25 patients in a cycle schedule consisting of three weeks of treatment followed by a rest period of two weeks for a total of five cycles. Subjects will be evaluable only if they have received at least one dose of maintenance treatment. The salvage transplant is not part of this study.

Secondary objective:

To explore changes in frequency and molecular signature in the multiple myeloma stem cell (MMSC) fraction based on flow-cytometric assays and gene expression profiling before and after the experimental treatment and to correlate outcome with expression levels of RARĪ±2 at time of relapse.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date November 2016
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Diagnosis of relapsed multiple myeloma

- Recent salvage transplant (= 6 months but = 45 days post-transplant prior to study enrollment) for relapse

- 18-75 years of age at the time of study entry

- Platelet count =70K/mm3 un-transfused

- Resolution of all transplant-related toxicity to = grade 2 per CTCAE v.4

- Left ventricular ejection fraction as measured by ECHO or MUGA should be = 40%

- Creatinine of = 2 mg/dl and a calculated GFR of >50mL/min/1.73m2

- A total bilirubin, ALT, AST, and alkaline phosphatase of = 2 ULN

- Performance status of 0-2 based on the ECOG criteria. Patients with performance status 3 or 4, based solely on bone pain, are also eligible, provided that there is a source document to verify this

- Prospective study participants must be informed of the investigational nature of the study and must have signed an IRB-approved informed consent form in accordance with institutional and federal guidelines

Exclusion Criteria:

- Prior allogeneic transplant

- Greater than grade 2 motor neuropathy or greater than grade 3 sensory neuropathy at screening

- Uncontrolled diabetes

- Recent (< 6 months) myocardial infarction, unstable angina, CABG or stent placement in the last 2 years, difficult-to-control congestive heart failure, uncontrolled hypertension (systolic blood pressure > 160 mm or a diastolic BP > 110 mm under normal conditions and while on appropriate anti-hypertensive medications), or difficult- to-control cardiac arrhythmias

- Evidence of QT prolongation and/or torsades de pointes (TdP) on EKG.

- Any co-morbid condition that poses a greater threat to the patient's life expectancy than the recurrent myeloma

- No concurrent malignancy with a life expectancy of less than two years, or one that requires ongoing chemotherapeutic intervention at screening

- Presence of an infection that requires intravenous antibiotics

- Pregnant or nursing females. Any patient of reproductive potential may not participate unless he/she has agreed to use an effective contraceptive method as covered during the informed consent process

- Known history of an HIV seropositive test

Study Design


Intervention

Drug:
ATRA

Celecoxib

Itraconazole


Locations

Country Name City State
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety 6 months
Secondary Blood and Bone Marrow Aspirate Samples as a measure of changes to the MMSC (multiple myeloma stem cell) fraction. 6 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04083534 - First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM) Phase 1/Phase 2
Recruiting NCT06119685 - IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers Phase 1/Phase 2
Active, not recruiting NCT05577000 - Anti-BCMA Chimeric Antigen Receptor T Cells for Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT01118689 - Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia Phase 1
Withdrawn NCT04802031 - Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma Phase 2
Active, not recruiting NCT00603447 - Phase 1b Multicenter Study of Carfilzomib With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma Phase 1
Active, not recruiting NCT02722668 - UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep Phase 2
Active, not recruiting NCT04965155 - A Trial for Relapsed Multiple Myeloma Patients (Isatuximab-dexamethasone) Phase 2
Completed NCT00592579 - A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma Phase 2
Recruiting NCT06304636 - Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma Phase 1
Completed NCT03158688 - Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. Phase 3
Completed NCT04434469 - A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma Phase 1
Completed NCT01080391 - Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma Phase 3
Not yet recruiting NCT06348108 - Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT01949532 - Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and Renal Disease Phase 1
Active, not recruiting NCT04398485 - A Study of ION251 Administered to Patients With Relapsed/Refractory Multiple Myeloma Phase 1
Recruiting NCT03091933 - Antiminor Histocompatibility Complex (MiHA) T Cells for Patients With Relapsed Hematologic Malignancies Following Matched HSCT (Guided Lymphocyte Immunopeptide Derived Expansion) Phase 1/Phase 2
Completed NCT01272466 - Vaccination With Peptides From Anti-apoptotic Proteins in Relapsed Multiple Myeloma Phase 1/Phase 2
Recruiting NCT05896228 - Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma Phase 2
Terminated NCT04119336 - Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Myeloma Phase 2