Trial of Lenalidomide/dexamethasone With or Without Elotuzumab inSubjects with Previously Untreated Multiple Myeloma.
- Conditions
- Mieloma Múltiple no tratado previamente.MedDRA version: 14.0Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022445-20-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 748
1) Signed Written Informed Consent
a) Subject is, in the investigator's opinion, willing and able to comply
with the protocol requirements.
b) Subject 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care, with the understanding that consent may be withdrawn by the
subject at any time without prejudice to their future medical care.
2) Target Population
a) Age >or= 18 years or legal age of consent per local regulations.
b) ECOG performance status c) Life-expectancy > 3 months.
d) Newly diagnosed ,untreated, symptomatic, documented myeloma
AND;
i) Who are not candidates for high-dose therapy plus SCT because of
age (>or= 65 years) or coexisting conditions AND;
ii) Measureable disease: serum IgG, IgA, IgM M-protein >or= 0.5 g/dL
or serum IgD M-protein >or= 0.05 g/dL or >or= 200 mg urinary Mprotein
excretion /24-hour.
3) Age and Reproductive Status
a) Women of childbearing potential (WOCBP) and men must be using 2
acceptable methods of contraception to avoid pregnancy throughout the
study for a period of at least 1 month (4 weeks) before and women for
up to 8 weeks, men for up to 90 days after the last dose of
investigational product in such a manner that the risk of pregnancy is
minimized.
b) WOCBP must have a negative serum or urine pregnancy test
(minimum sensitivity 25 IU/L or equivalent units of HCG). The first
should be performed within 10 14 days and the second within 24 hours
prior to the start of the investigational product. A prescription for
lenalidomide for a female of childbearing potential must not be issued by
the prescriber until negative pregnancy tests have been verified by the
prescriber.
c) Women must not be breastfeeding.
d) Women who are not of childbearing potential and men.
e) Sexually active fertile men must use effective birth control if their
partners are WOCBP. Men must agree to use a latex condom and a
second form of birth control during sexual contact with WOCBP, even if
they have had a successful vasectomy, and must agree to not donate
semen during study drug therapy and for 90 days after therapy.
f) Subjects must be willing to refrain from blood donations during study
drug therapy and for 8 weeks after therapy.
4) To participate in this Pharmacogenetic Sample Amendment, subjects
must provide a signed Pharmacogenetic Blood DNA informed consent
and must have consented to participate in the main clinical trial
CA204006.
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 189
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 673
1) Target Disease Exceptions
a) Subjects with non-secretory or oligo-secretory or serum free lightchain only myeloma.
b) Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions.
c) Monoclonal Gammopathy of Undetermined Significance (MGUS) defined by all of the following: serum M protein < 3 g/dL, absence of lytic bone lesions, anemia, hypercalcemia and renal insufficiency related to monoclonal protein and (if determined) proportion of plasma cells in the bone marrow of 10% or less.
d) Diagnosis of Waldenstrom's disease or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
e) Plasma cell leukemia.
2) Medical History and Concurrent Diseases
a) Known or suspected cardiac amyloidosis; POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
b) Significant cardiac disease as determined by the investigator including:
i) Known or suspected cardiac amyloidosis;
ii) Congestive heart failure of Class III or IV of the NYHA classification;
iii) Uncontrolled angina, hypertension or arrhythmia;
iv) Myocardial infarction in past 6 months;
v) Any uncontrolled or severe cardiovascular disease.
c) Prior cerebrovascular event with persistent neurologic deficit.
d) Known history of, or documented positive hepatitis B or C or HIV infection.
e) Any medical conditions that, in the investigator's opinion, would impose excessive risk to the subject. Examples of such conditions include:
i) Any uncontrolled disease, such as pulmonary disease, infection, seizure disorder;
ii) Active infection of Hepatitis A or that requires parenteral antiinfective treatment;
iii) Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.
f) Prior or concurrent malignancy, except for the following:
i) Adequately treated basal cell or squamous cell skin cancer;
ii) Cervical carcinoma in situ;
iii) Adequately treated Stage I or II cancer from which the subject is currently in complete remission;
iv) Or any other cancer from which the subject has been disease-free for g) Uncontrolled diabetes.
h) Unable to tolerate thromboembolic prophylaxis including, aspirin, Coumadin (warfarin) or low-molecular weight heparin as clinically indicated.
3) Physical and Laboratory Test Findings
a) Corrected serum calcium >or= 14 mg/dl within 2 weeks of randomization.
b) Absolute neutrophil count < 1000 cells/mm3. No growth factors allowed within 1 week of randomization.
c) Platelets < 75,000 cell/mm3 (75 x 10E9/L). Qualifying laboratory value must occur at most recent measurement prior to randomization and must be no more than 14 days prior to randomization. No transfusions are allowed within 72 hours prior to qualifying laboratory value.
d) Hemoglobin < 8 g/dL. Qualifying laboratory value must occur at most recent measurement prior to randomization and must be no more than 14 days prior to randomization. No transfusions are allowed within 72 hours prior to qualifying laboratory value.
e) Total bilirubin >or= 2 x ULN, and direct bilirubin >or= 2.0 mg/dL.
f) AST or ALT >or= 3 x ULN.
g) Creatinine clearance (CrCl) < 30 mL/min measured by 24-hour urine
collection or estimated by the Cockcroft and Gault formula.
4) Prior Therapy or Surgery
a) Administration of systemic chemotherapy, biological, immunotherapy, clarithromycin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method