Overview

Subcutaneous Velcade Plus Oral Melphalan and Prednisone or Plus Cycloposphamide and Prednisone or Plus Prednisone

Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
This protocol is a single-arm, three-cohort, phase II multicenter study designed to assess the safety and the efficacy of three all-oral combinations: Velcade with continuous low-dose melphalan and prednisone (VMP) or with continuous low-dose cyclophosphamide and prednisone (VCP) or Velcade with low-dose prednisone could be effective and well tolerated (VP).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Myeloma Network
Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborators:
Fondazione EMN Italy Onlus
Fondazione Neoplasie Sangue Onlus
Treatments:
Bortezomib
Cyclophosphamide
Melphalan
Prednisone
Criteria
Inclusion Criteria:

- Age ≥ 75 years old or age < 75 years with abnormal cardiac, pulmonary, renal or
hepatic function (unsuitable for protocol with standard inclusion/exclusion criteria).

- Patient is, in the investigator(s) opinion willing and able to comply with the
protocol requirements.

- Patient has given voluntary written informed consent before performance of any
study-related procedure not part of normal medical care, with the understanding that
consent may be withdrawn by the patient at any time without prejudice to their future
medical care.

- Male patient agrees to use an acceptable method for contraception (i.e., condom or
abstinence) during study drug therapy (including dose interruption) and for 4 weeks
after discontinuation of Velcade therapy.

- Female patient is either post-menopausal for 24 consecutive months or surgically
sterilised or agree to continuous abstinence from heterosexual sexual contact or
willing to use two acceptable method of birth control at the same time (one highly
effective method and one additional effective method) (Highly Effective Methods:
Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal
ligation; partner's vasectomy; Additional Effective Methods: Latex condom; Diaphragm;
Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug
therapy (including dose interruption) and for 4 weeks after discontinuation of
therapy.

- Patient was a newly diagnosed multiple myeloma based on standard criteria

- Patient has measurable disease, defined as follows:

- Secretory myeloma: any quantifiable serum monoclonal protein value (generally, but not
necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA
M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours;

- Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one
plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs
(i.e., MRI or CT scan).

- Patient has a Karnofsky performance status > 50%.

- Patient has a life-expectancy >3 months

- Pretreatment clinical laboratory values within 14 days of enrolment:

- platelet count ≥ 80x109/L

- hemoglobin ≥ 8 g/dL

- absolute neutrophil count (ANC) ≥ 1.0x109/L

- AST ≤ 2.5 times the upper limit of normal

- ALT ≤ 2.5 times the upper limit of normal

- total bilirubin ≤ 1.5 times the upper limit of normal

- cleareance creatinine ≥ 20 ml/min

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality or psychiatric illness that
prevented the subject from signing the informed consent form or placed the subjects at
unacceptable risk.

- Previous treatment with anti-myeloma therapy (does not include radiotherapy,
bisphosphonates, or a single short course of steroid; < to the equivalent of
dexamethasone 40 mg/day for 4 days).

- Pregnant or lactating females

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

- Peripheral neuropathy or neuropatic pain grade 2 or higher, as defined by National
Cancer Institute Common Toxicity Criteria (NCI CTC) 3.0

- Infiltrative pulmonary disease