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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 126 MM


News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


HO126 news

 

The HOVON126 Imaging protocol for PET-FDG side study, a User Guide KEOSYS (Advanced Medical Imaging Software)and User Guide Imagys (only in Dutch) are now available.

 


1. Overview



Summary

Ixazomib citrate-thalidomide-low dose dexamethasone induction followed by maintenance therapy with ixazomib citrate or placebo in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplantation; a randomized phase II trial


Status

closed


Members

Participating groups: NMSG



Type of study

Prospective Phase I/II study


Echelon level

Limited site selection


Echelon level specification

The number of participating sites is limited due to financial reasons


Type of monitoring for this study

Site evaluation visits


Target number of patients

142


Current number of patients

143


Date of activation

24-Nov-2014


Approved by

METC VUmc
CCMO


Study objectives

• Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria (see appendix A)
• Measurable disease according to the IMWG criteria (see appendix A)
(If plasmacytoma is the only measurable parameter, the patient is not allowed to be included in the study, because of difficult response evaluation)
• Age ≥ 66 years or patients ≤ 65 years not eligible for ASCT
• WHO performance status 0-3 for patients <75 years and WHO performance status 0-2 for patients ≥ 75 years (see appendix D)
• Absolute neutrophil count (ANC) ≥ 1.0 x109/l and platelet count ≥ 75x109/l , unless related to bone marrow infiltration by malignant plasmacells
Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment
• Written informed consent
• Patient gives consent for extra bone marrow and blood sampling
• Negative pregnancy test at study entry or at least 1 year post-menopausal or surgically sterile before study entry
• A female patient of childbearing potential, agrees to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program (for thalidomide) OR agrees to completely abstain from heterosexual intercourse. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception)
• Male patients, even if surgically sterilized, (i.e., status post vasectomy) must agree to practice effective barrier contraception during the entire study period and through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program (for thalidomide), OR agrees to completely abstain from heterosexual intercourse (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).


2. Patient eligibility criteria



Inclusion criteria

Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria
Measurable disease according to the IMWG criteria (see appendix A) (If plasmacytoma is the only measurable parameter, the patient is not allowed to be included in the study, because of difficult response evaluation).
Age ≥ 66 years or patients ≤ 65 years not eligible for ASCT
WHO performance status 0-3 for patients <75 years and WHO performance status 0-2 for patients ≥ 75 years
Absolute neutrophil count (ANC) ≥ 1.0 x109/l and platelet count ≥ 75x109/l , unless related to bone marrow infiltration by malignant plasmacells. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment
Written informed consent
Negative pregnancy test at study entry or at least 1 year post-menopausal or surgically sterile before study entry
A female patient of childbearing potential, agrees to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program (for thalidomide) OR agrees to completely abstain from heterosexual intercourse. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized, (i.e., status post vasectomy) must agree to practice effective barrier contraception during the entire study period and through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program (for thalidomide), OR agrees to completely abstain from heterosexual intercourse (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)


Exclusion criteria

• Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
• Systemic AL amyloidosis
• Polyneuropathy, grade 3 or higher or grade 2 with pain on clinical examination during the screening period
• Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
• Severe pulmonary dysfunction (Modified Medical Research Counsil dyspnea scale classification III-IV)
• Significant hepatic dysfunction (total bilirubin ≥ 1.5 x ULN or transaminases ≥ 3 times normal level) except patients with Gilbert’s syndrome as defined by > 80% unconjugated bilirubin
• Creatinine clearance <30 ml/min or Calculated Glomerular Filtration Rate [ml/min/1.73m2] <30.
• Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John’s wort.Pre-treatment with cytostatic drug, IMIDs or proteasome inhibitors. Radiotherapy or a short course of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or equivalent) are allowed. Radiotherapy should not be given within 14 days before enrollment. In case of palliative radiotherapy for pain control and if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib citrate
• Not able and/or not willing to use adequate contraception
• Female patients who are lactating or have a positive serum pregnancy test during the screening period
• Major surgery within 14 days before enrollment
• Central nervous system involvement
• Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive
• Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib citrate including difficulty swallowing
• Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
• Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial
• Any serious medical or psychiatric illness, or familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC - Clinical Trial Center
Postbus 2040
3000 CA Rotterdam
Phone number: +31 10 7041560 (working days 9.00-17.00)
Fax nuber: +31 10 7041028
TOP address: href="https://www.hdc.hovon.nl/top">http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Local patient code (optional)
Sex
Age at date of registration
Date written informed consent
Specific items patient gives consent for (see ICF)
Eligibility criteria
Specific items:
‘Risk Management Program’ discussed with patient


4. Participating parties



Principal Investigator(s)

Prof. N. Abildgaard (Odense Universitetshospital)
Prof. Dr. S. Zweegman (VUMC)


Co-Investigator(s)

Prof. Dr. H.M. Lokhorst (VUMC)
Dr. U.H Mellqvist (Sahlgrenska sjukhuset)
Prof. Dr. P. Sonneveld (Erasmus MC - Centrum)
Dhr. A. Waage (St. Olav univ Hospital)


Coordinating Investigator(s)

Prof. N. Abildgaard (Odense Universitetshospital)
Dr. M. Hansson (Skanes University Hospital Lund)
Mw. Dr. E. Haukas (Stavanger Univ. Hosp.-Rogaland Hosp.)
Prof. Dr. S. Zweegman (VUMC)


Statistician(s)

Dhr. Dr. B. van der Holt (Erasmus MC - Daniel)


Trial Manager(s)

Mw. S. Cunha (Erasmus MC - Daniel)


Central Data Manager(s)

A. Verbrugge (Erasmus MC - Daniel)


Monitor - Site Evaluation Visits

Mw. W.M Keller (Erasmus MC - Daniel)
Mw. T. van de Klundert (Erasmus MC - Daniel)


Other functions

Central Coordinator - QoL - Mw. S. Cunha (Erasmus MC - Daniel)
Central Coordinator - Special Investigations - Dhr.dr. M. van Duin (Erasmus MC - Daniel)
Central Pharmacist - Apotheek VUmc (VUMC)
Reviewer - Cytogenetics - Mw. Dr. M.J.P.L. Stevens-Kroef (Radboudumc)
Reviewer - Imaging - Mw. J.M. Zijlstra-Baalbergen (VUMC)


Principal investigator

S. Zweegman (S.Zweegman@vumc.nl)


Coordinating investigator(s)

N. Abildgaard (niels.abildgaard@ouh.regionsyddanmark.dk
M. Hansson (markus.hansson@skane.se)
E. Haukås (haer@sus.no)


Trial manager

S. Cunha (s.cunha@erasmusmc.nl)


Central data management

A. Verbrugge (a.verbrugge.1@erasmusmc.nl)


5. Participating sites



Site
Included patients *
DK-Aalborg-Aalborg Hospital
4
DK-Aarhus C-Aarhus University Hospital
1
DK-Copenhagen-Rigshospitalet Copenhagen
2
DK-Herlev-Herlev Hospital
5
DK-Odense-Odense Universitetshospital
3
NL-Alkmaar-MC Alkmaar
2
NL-Amersfoort-Meander MC
9
NL-Amsterdam-AMC
2
NL-Amsterdam-VUMC
10
NL-Arnhem-Ziekenhuis Rijnstate
4
Show 30 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol



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