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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 April 2019 |
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Main ID: |
EUCTR2006-005890-24-GB |
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Date of registration:
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10/10/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Myeloma X Relapse (Intensive) - A randomised controlled trial to determine the role of a second autologous stem cell transplant as consolidation therapy in patients with relapsed multiple myeloma following prior high-dose chemotherapy and autologous stem cell rescue. - Myeloma X Relapse (Intensive)
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Scientific title:
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Myeloma X Relapse (Intensive) - A randomised controlled trial to determine the role of a second autologous stem cell transplant as consolidation therapy in patients with relapsed multiple myeloma following prior high-dose chemotherapy and autologous stem cell rescue. - Myeloma X Relapse (Intensive) |
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Date of first enrolment:
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02/11/2007 |
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Target sample size:
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460 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005890-24 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: The trial also includes a single intervention registration phase
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
The principal inclusion criteria for registration are:
1) Diagnosed with symptomatic including non-secretory myeloma previously treated with standard chemotherapy and autologous transplantation
2) Requiring therapy for first Progressive Disease
3) Demonstrate Progressive Disease requiring treatment at least 18 months from time of first transplant
4) Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
5) Aged at least 18 years
6) Adequate full blood count, renal function, hepatobililiary function, pulmonary function and cardiac function within 14 days of registration
7) If female and of childbearing potential, must have a negative pregnancy test within 24 hours prior to start of PAD (bortezomib, doxorubicin, dexamethasone) therapy
8) Provide written informed consent
The principal inclusion randomisation are: As at registration, plus
1) Responded or have Stable Disease, following PAD re-induction chemotherapy
2) Adequate stem cell mobilisation defined as =2x10^6 CD34+ cells/kg or = 2x10^8 PBMC/kg available for transplantation (including cells stored from a previous harvest)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
The principal exclusion criteria for registration are:
1) Received therapy for their relapsed disease other than local radiotherapy, therapeutic plasma exchange, or dexamethasone up to a maximum of 200mg
2) Greater than or equal to Grade 2 peripheral neuropathy within 14 days before registration
3) Known HIV or Hepatitis B/C seropositivity (testing is not required for the trial).
4) Use of any investigational drug within 4 weeks prior to registration, or scheduled to receive any investigational drug during the course of the study.
5) Known resistance to combined bortezomib, doxorubicin and dexamethasone (PAD) therapy
6) Known history of allergy contributable to compounds containing boron or mannitol 7) Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the patient’s participation in this study.
8) Previous or concurrent malignancies at other sites, with the exception of appropriately treated localised epithelial skin or cervical cancer. Patients with remote histories (>5 years) of other cured tumours may be entered.
9) Unwilling to use adequate contraception during the study and for 6 months after the end of the study treatment if female of childbearing potential, or male whose partner is a female of childbearing potential unless they are surgically sterile.
The principal exclusion criteria for randomisation are:
1) Progressive Disease, according to International Uniform Response Criteria for myeloma, following PAD re-induction therapy or stem cell mobilisation
2) Received any therapy for their relapsed disease other than local radiotherapy or protocol PAD treatment prior to randomisation
3) Any contraindication to protocol treatment that would make the patient ineligible
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Relapsed myeloma previously treated with chemotherapy and autologous stem cell transplantation
MedDRA version: 9.1
Level: LLT
Classification code 10051381
Term: Myeloma recurrence
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Intervention(s)
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Trade Name: Velcade
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: bortezomib
CAS Number: 179324-69-7
Other descriptive name: BORTEZOMIB
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 1.3-
Product Name: doxorubicin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214928
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 9-
Product Name: Dexamethasone
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50022
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Product Name: cyclophosphamide
Pharmaceutical Form: Tablet
INN or Proposed INN: CYCLOPHOSPHAMIDE
CAS Number: 50180
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: range
Concentration number: 300-400
Product Name: Melphalan
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: MELPHALAN
CAS Number: 148823
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 200-
Product Name: Granulocyte colony stimulating factor (G-CSF)
Pharmaceutical Form: Powder and solvent for solution for injection
CAS Number: 8000048217
Other descriptive name: GRANULOCYTE COLONY STIMULATING FACTOR
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Primary Outcome(s)
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Main Objective: To determine the effect on freedom-from disease progression of a second autologous stem cell transplant (ASCT) compared with low-dose consolidation, following re-induction chemotherapy, in patients with relapsed myeloma previously treated with high-dose chemotherapy and ASCT
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Secondary Objective: •To assess the response rate to PAD in patients relapsing with myeloma following a previous autograft
•To assess the overall response rate following high-dose chemotherapy (with autologous stem cells) compared with low-dose consolidation
•To determine the overall survival
•To determine the safety and toxicity of a second ASCT
•To assess safety and toxicity of PAD therapy
•To assess the feasibility of stem cell collection at relapse from a prior ASCT, following re-induction
•Effect of type of PBSC mobilisation and harvest on time to disease progression
•To determine the impact of the treatment strategies on Quality of Life (QoL)
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Primary end point(s): The primary end-point is to determine the effect on freedom-from disease progression of a second autologous transplant compared with low-dose consolidation following re-induction therapy
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Secondary ID(s)
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HM05/7287
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ISRCTN60123120
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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