Combination of Bendamustine, Bortezomib and Velcade as preferred treatment of patients with newly diagnosed multiple myeloma not eligible for high dose chemotherapy followed by stem cell transplantatio

Phase 1

• Conditions: multiple myeloma (symptomatic, newly diagnosed) not eligible for high dose chemotherapy and subsequent stem cell transplantaion; MedDRA version: 19.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-005485-19-DE
• Lead Sponsor: Ruprecht-Karls-University Heidelberg, Med Faculty represented by University Clinic HD and its Comm. Director

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-18
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

1.Newly diagnosed multiple myeloma requiring systemic treatment (according to CRAB criteria as specified in the appendix) with following characteristics: Subject is not a candidate for high-dose chemotherapy and stem cell transplantation due to age, presence of comorbidities likely to have a negative impact on tolerability of HDT-SCT, or subject preference
2.Measurable disease, defined as any quantifiable monoclonal protein value, defined by at
least one of the following three measurements (International Working Group , 2003 and Durie et al, 2006) (see appendix II)
a.Serum M-protein = 10g/l
b.Urine light-chain (M-protein) of = 200 mg/24 hours
c.Serum FLC assay: involved FLC level = 10 mg/dl provided sFLC ratio is abnormal
3.Age =18 years
4.WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by co-morbid conditions) 5.For women of childbearing potential: negative pregnancy test at inclusion
6.All men and women of childbearing potential must be willing and capable to use highly effective contraception during the complete therapy. [CPMP/ICH/286/95 mod: Highly effective
methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e.,less than 1% per year) when used consistently and correctly. Examples of Highly effective and additional
methods:- Intrauterine device (IUD), Hormonal (birth control pills, injections, implants), Tubal ligation,Partner’s vasectomy. Additional effective methods: Male condom, Diaphragm, Cervical Cap]
7. All patients must agree to abstain from donating blood while on study
8.Ability to understand character and individual consequences of the clinical trial
9.Written informed consent (must be available before enrolment in the trial)

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 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

Exclusion Criteria

Subjects presenting any of the following criteria will not be included in the trial:
1.Patient has known hypersensitivity to bortezomib, bendamustine, prednisone or to any of the constituent compounds (incl. boron and mannitol).
2.Systemic AL amyloidosis (except for patients with AL amyloidosis of the skin or the bone marrow)
3.Previous chemotherapy or radiotherapy during the past 5 years except patient’s local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 3 weeks prior to study entry.)
4.Plasma cell leukaemia which requires the presence of 20% of plasma cell in peripheral blood leukocytes and at least 2/nl.
5.Severe cardiac dysfunction (NYHA classification III-IV)
6.Significant hepatic dysfunction (serum bilirubin = 2 mg/dl or ASAT and/or ALAT = 2.5 times normal level), unless related to myeloma
7.Patients known to be HIV-positive
8.Patients with active, uncontrolled infections
9.Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0)
10.Second malignancy within the past 5 years except:
a.Adequately treated basal cell or squamous cell skin cancer,
b.Carcinoma in situ of the cervix, or
c.Prostate cancer < Gleason score 6 with undetectable prostate-specific antigen (PSA) over 12 months, or
d.Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins), or
e.Similar condition with an expectation of > 95 % 5-year disease free survival
11.Patients with acute diffuse infiltrative pulmonary and pericardial disease
12.Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia
13.Platelet count < 50 x 109/l (transfusion support within 14 days before the test is not allowed), unless related to myeloma
14.Hemoglobin < 7.5g/dl, unless related to myeloma
15.Absolute neutrophil count (ANC) < 0.75 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed), unless related to myeloma
16.Pregnancy and lactation
17.Participation in other clinical trials within one month prior to enrolment except patients for supportive care studies and vaccination studies. (Note: This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified