Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01526694
Other study ID # BDT-01-2011
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 2012
Est. completion date April 8, 2017

Study information

Verified date July 2018
Source Azienda Ospedaliera di Bolzano
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a combination chemotherapy consisting of Bendamustine + Dexamethasone + Thalidomide in patients with multiple myeloma (MM) after treatment with lenalidomide and bortezomib or which are ineligible to one of these drugs.


Description:

Eligible patients will be treated according to the following scheme until the occurrence of maximum response, dose limiting toxicity or disease progression. Repeat cycles every 28 days for a maximum of 6 cycles and a minimum of 4.

- Bendamustine 60 mg/m2 i.v. days 1, 8, 15

- Dexamethasone 20 mg p.o. days 1,8 , 15, 22

- Thalidomide 100 mg daily p.o. days 1-28; initial dose of 50 mg/day, with an increment to 100 mg after the first 15 days of treatment.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 8, 2017
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Understand and voluntarily sign an informed consent form.

- Age 18 years at the time of signing the informed consent form.

- Life expectancy of at least 3 months

- Able to adhere to the study visit schedule and other protocol requirements

- Relapsed or refractory active MM (according to the International Myeloma Working Group guidelines) after treatments containing bortezomib and lenalidomide or ineligible (intolerance or toxicity) to one of these drugs with detectable myeloma protein in blood or urine.

- Disease free of prior malignancies for at least 5 years.

- All previous multiple myeloma treatments, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, except corticosteroids therapy.

- ECOG performance status <2 at study entry, unless it is due to MM.

- At least the following laboratory findings at the day of treatment start:

- Platelet count = 75 x 10^9/L without transfusional support within 7 days.

- Neutrophil count > 1.5 x 10^9/L without G-CSF.

- Corrected calcium = 14 mg/dL (3.5 mmol/L).

- AST: = 2.5 times the normal upper limit.

- ALT: = 2.5 times the normal upper limit.

- Total bilirubin: = 1.5 times the normal upper limit.

- Measured or calculated creatinine clearance of = 20 mL/minute

- Women of child bearing potential and male patients whose partner is a woman of child bearing potential must be prepared to use two effective methods of contraception both before and during protocol treatment, or commit to absolute and continuous abstinence.The pregnancy test must be negative 14-28 days and 72 hours before treatment start. Only in case of hysterectomy or presence of menopause for at least 24 consecutive months pregnancy tests as well as contraception are not necessary. Men must not father a child for up to 6 months following cessation of treatment and must use condoms.

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

- Pregnant or breast feeding females.

- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

- Patients with contraindications for treatment with bendamustine, dexamethasone and thalidomide.

- Uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (= Lown 3).

- Use of any other experimental drug or therapy within 28 days of baseline.

- Known hypersensitivity to thalidomide or purine analogues

- Concurrent use of other anti-cancer agents or treatments other stated in this treatment plan.

- Peripheral neuropathy grade =2 according to WHO

- Known positive for HIV or infectious hepatitis, type A, B or C.

- Major surgery less than 30 days before start of treatment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bendamustine
Bifunctional alkylating agent consisting of a purine and amino acid antagonist (a benzimidazole ring) and an alkylating nitrogen mustard moiety.
Thalidomide
Thalidomide can directly inhibit the growth and survival of myeloma cells, by oxidative damage to DNA mediated by free radicals. The drug can induce apoptosis even in drug resistant myeloma cells. Thalidomide modulates cell adhesion molecule expression, so it may interfere with the mutually stimulatory interactions between myeloma cells and the bone marrow microenvironment.
Dexamethasone
It's a corticosteroid.

Locations

Country Name City State
Italy Ospedale S. Martino Belluno
Italy Division of Hematology and CBMT Bolzano BZ
Italy Presidio Ospedaliero di Camposampiero Camposampiero Padova
Italy Ospedale di Castelfranco Veneto Castelfranco Veneto
Italy Ospedale Civile di Dolo Dolo
Italy AULSS 2 Feltre Feltre
Italy Azienda Ospedaliera Universitaria G. Martino Messina
Italy Ospedale dell'Angelo di Mestre Mestre
Italy A.O di Padova Ematologia Padova
Italy A.O di Padova Ematologia e Immunologia Clinica Padova
Italy AULLS 18 di Rovigo Rovigo
Italy Ospedale di Trento - P.O. S. Chiara Trento
Italy Ospedale Ca Foncello Treviso
Italy A.O.U Ospedali Riuniti di Trieste Trieste
Italy A.O.U Ospedali Riuniti di Trieste Medicina II Trieste
Italy A.O.U S. Maria della Misericordia Udine
Italy Ospedale Policlinico G.B Rossi (Borgo Roma) Ematologia Verona
Italy Ospedale Policlinico G.B Rossi (Borgo Roma) Medicina II Verona
Italy AULSS 6 Vicenza Vicenza

Sponsors (2)

Lead Sponsor Collaborator
Azienda Ospedaliera di Bolzano Mundipharma Pte Ltd.

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate The proportion of patient with a Complete Response (CR) or Very Good Partial Response or partial response 18 months
Primary Incidence of haematological toxicity of BDT The incidence of haematological toxicities is the proportion of patients with haematological toxicity 18 months
Secondary Time to treatment Failure (TTF) To evaluate time to treatment failure 18 months
Secondary Survival (OS) To evaluate overall survival 18 months
Secondary Disease Free Survival (DFS) To evaluate disease free survival 18 months
See also
  Status Clinical Trial Phase
Recruiting NCT05027594 - Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02412878 - Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma Phase 3
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05971056 - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma N/A
Recruiting NCT05243797 - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation Phase 3
Active, not recruiting NCT04555551 - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Recruiting NCT03570983 - A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion Phase 2
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT03665155 - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody Phase 1/Phase 2
Completed NCT02812706 - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients Phase 1/Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1