A Phase 3 Relapsed or Refractory Multiple Myeloma - Open label with or without Elotuzumab.

Phase 1

• Conditions: Relapsed or Refractory Multiple Myeloma; MedDRA version: 13.1Level: 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: EUCTR2010-020347-12-FR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-06
• Last Update Posted: 25 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.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) Documented evidence of multiple myeloma and
i) Received between 1 to 3 prior lines of therapy with documented progression by EBMT criteria after the most recent therapy 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 M-protein excretion /24-hour.
e) Prior lenalidomide exposure is permitted only if they fulfill all of the following:
i) Best response achieved was >or= PR
ii) Were not refractory to prior lenalidomide defined as no progression while receiving lenalidomide or within 9 months of last dose of lenalidomide
iii) Subject did not discontinue lenalidomide due to a Grade >or= 3 related AE
iv) Subject did not receive more than 9 cycles of lenalidomide and had at least 9 months between the last dose of lenalidomide and progression
3) Age and Reproductive Status
a) Men and women of childbearing potential (WOCBP) 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) Women 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) 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.
e) Subjects must be willing to refrain from blood donations during study drug therapy and for 8 weeks after therapy.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 540

Exclusion Criteria

1) Target Disease Exceptions
a) Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
b) Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 10E9/L).
2) Medical History and Concurrent Diseases
a) All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade b) Known or suspected cardiac amyloidosis; POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
c) 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
d) Prior cerebrovascular event with persistent neurologic deficit
e) Known history of, or documented positive hepatitis B or C or HIV infection
f) 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 anti-infective treatment
iii) Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent
g) 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 h) Uncontrolled diabetes (defined as Hgb A1C >or= 8.0% and fasting glucose >or= 160 mg/dl).
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= 14 mg/dl within 2 weeks of randomization (despite appropriate measure such a short course of steroids, bisphosphonates, hydration, calcitonin)
b) Absolute neutrophil count < 1000 cells/mm3. No growth factors allowed within 1 week of randomization.
c) Platelets < 75,000 cell/mm3 (75 x 109/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) No major surgery within 4 weeks or radiation therapy within 2 weeks prior to randomization.
b) Administration of chemotherapy, biological, immunotherapy, or investigational agent (therapeutic or diagnostic) within 3 weeks prior to randomization (14 days for n

Study & Design

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