Trial of Elotuzumab/Thalidomide/dexamethasone in subjects with Relapsed and/or Refractory Multiple Myeloma
- Conditions
- Relapsed and/or Refractory Multiple MyelomaMedDRA version: 14.1Level: 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
- EUCTR2011-005121-49-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
- 40
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.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) Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 for the TdE safety-lead in cohort; performance status of 0 - 2 for additional subjects.
b) Confirmed diagnosis of previously treated multiple myeloma with documented progression by IMWG criteria after or during the most recent therapy. There is no limit to the number of prior lines of therapy.
c) Measurable disease as defined by at least one of the following:
i) Serum IgG, IgA or IgM M-protein >or= 0.5 g/dL, or serum IgD M-protein >or= 0.05 g/dL, OR
ii) Urine M protein >or= 200 mg excreted in a 24-hour collection sample; OR
iii) Involved serum free light chain level >or= 10 mg/dL provided the free light chain ratio is abnormal
3) Age and Reproductive Status
a) Men and women, age >or= 18 years or legal age of consent per local regulations
b) Women of childbearing potential (WOCBP) must use highly effective methods of birth control for at least 4 weeks before study treatment, throughout the study, even in the setting of dose interruptions, and for 3 months after the last dose of study treatment to minimize the risk of pregnancy. WOCBP must follow instructions for birth control for the entire duration of the study including a minimum of 90 days after dosing has been completed.
Contraceptive methods must include at least one highly effective method AND one additional effective barrier method.
The use of IUDs shall be at the discretion of the investigator.
Hormonal contraceptives may not be used for contraception unless a drug-drug interaction study has demonstrated that the PK of the hormone based contraceptive has not been adversely affected. The use of hormone based contraceptives is not otherwise restricted.
c) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the first dose of investigational product.
d) Women must not be breastfeeding.
e) Subjects must be willing to refrain from blood donations during study drug therapy and for 90 days after therapy.
f) Men must agree to use a latex condom during sexual contact with a pregnant woman or with a WOCBP during treatment and for 1 week after dose interruption and/or cessation of treatment, even if they have had a successful vasectomy, and must agree not to donate sperm during study drug therapy and for 90 days after therapy.
g) All subjects must follow instructions for birth control for the entire duration of the study and a minimum of 90 days after dosing has been completed.
4) Pharmacogenetic
To participate in the Pharmacogenetic Sample Amendment, subjects
must provide a signed Pharmacogenetic Blood DNA informed consent.
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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
1) Target Disease Exceptions
a) Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
b) MGUS, smoldering myeloma or Waldenström?s macroglobulinemia.
c) Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109 /L).
d) Subjects with non-secretory myeloma.
2) Medical History and Concurrent Diseases
a) 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, or seizure disorder
ii) Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent
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
vi) Prior cerebrovascular event with persistent neurologic deficit
c) Prior or concurrent malignancy, except any malignancy from which the subject has been disease-free for >or= 5 years
d) Known HIV infection
e) Active hepatitis A, B, or C
f) Uncontrolled diabetes
g) Grade >or= 2 neuropathy.
h) Any residual AEs from prior chemotherapy, surgery, or radiotherapy that have not resolved to < Grade 2.
i) Unable to tolerate thromboembolic prophylaxis including as clinically indicated, aspirin, Coumadin (warfarin) or low-molecular weight heparin.
3) Physical and Laboratory Test Findings
a) Corrected serum calcium >or= 11.5 mg/dL within 2 weeks of enrollment (despite appropriate measures such as hydration, a short course of steroids, bisphosphonates, or calcitonin).
b) Absolute neutrophil count < 1000 cells/mm3. No growth factors allowed within
1 week of enrollment.
c) Platelets < 75,000 cell/mm3 (75 x 109/L). Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours before qualifying laboratory value.
d) Hemoglobin < 8 g/dL. Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours before qualifying laboratory value.
e) Creatinine clearance < 30 mL/minute measured by 24-hour urine collection or estimated by the Cockcroft-Gault formula
Subjects with a measured or estimated creatinine clearance of 30-40 ml/minute on screening labs must have a repeat measurement or estimation of creatinine clearance by the Cockcroft-Gault formula within 72 hours of starting treatment to confirm eligibility (based on an estimated creatinine clearance of >or= 30 mL/minute).
f) Total bilirubin > 1.5 x ULN.
g) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >or= 3 x ULN.
4) Prior Therapy or Surgery
a) Major surgery within 4 weeks or radiation therapy within 2 weeks prior to Cycle 1
Day 1 (localized radiation therapy for palliative treatment acceptable).
b) Administration of chemotherapy, biological, immunotherapy, or investigational agent (therapeutic or diagnostic) within 3 weeks prior to Cycle 1 Day 1 (14 days for non-myelosuppressive therapy). Subjects should be 6 weeks from last dose of
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