E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Previously Treated Multiple Myeloma |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028228 |
E.1.2 | Term | Multiple myeloma |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to compare PFS after treatment with the tabalumab, bortezomib, and dexamethasone, to that of placebo, bortezomib, and dexamethasone in patients with relapsed/refractory MM. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives will include comparison of treatment and placebo arms for assesment of:
- Quality of response (QoR)
- Best overal response (BoR)
- Overall survival (OS)
- Time to progression (TTP)
- Time to next treatment (TNT)
- Duration of response (DOR)
- Time to first sceletal-related event (SRE)
- The incidence of clinically significant pain response
- To describe the population PK of tabalumab in patients with MM
Exploratory objectives
The exploratory objectives of the study are as follows:
- Biomarker objectives
- Health outcomes objectives
-Biomarker objectives
- Health outcomes objectives
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Have symptomatic and/or progressive multiple myeloma that was previously treated with at least 1 and no more than 3 prior lines of therapy, defined as follows (Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1, Blood. 2011;117(18):4691-4695).
-Have measurable disease
-Are ≥18 years of age
-Have given written informed consent prior to any study-specific procedures
-Have adequate organ function
-Treatment with prior autologous transplant is permitted
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E.4 | Principal exclusion criteria |
-Are enrolled in or discontinued from a clinical trial of any drug or device within 21 days prior to the first dose of assigned study treatment
•Have had less than a minimal response or have had progressive disease within 60 days of most recent therapy with a proteasome inhibitor
•Plan to proceed to autologous transplant for consolidation after treatment on Study JDCG
•Have an active infection or ongoing treatment for systemic infection (“ongoing treatment” does not include prophylactic anti-infectives), chest x-ray suggestive of tuberculosis, or history/risk of chronic/latent infection that may reactivate in the presence of study therapy
•Have positive test results for human immunodeficiency virus (HIV);, positive test results for hepatitis B defined as positive for hepatitis B surface antigen (HBsAg+), or positive for hepatitis B deoxyribonucleic acid(HBV DNA); positive test results for hepatits C virus (HCV) defined as positive for hepatitic antibody(HepCAb) and confirmed positive via the hepatitis C recombinant immunoblot assay, positive test results for hepatitis B, positive test results for hepatitis C virus (HCV).
•Have had significant allergy to human/humanized monoclonal antibodies that, in the opinion of the investigator, poses an unacceptable risk to the patient
•Have known hypersensitivity or contraindication to any of the study therapies or excipients
•Prior allogeneic hematopoietic stem cell transplant
•Prior therapy with experimental agents targeting BAFF, including LY2127399
•Have corrected QT (QTc) interval >500 msec on baseline 12-lead electrocardiogram (ECG)
•Have Waldenstrom’s macroglobulinemia
•History of malignancy for which the subject has not been disease-free for at least 3 years. Exceptions: patients with adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, are eligible regardless of the time of diagnosis/treatment.
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival (PFS) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 cycles after the last patient is enrolled and at least 70 progression-free survival (PFS)events are observed. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Dexamethasone, Bortezomib |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Brazil |
Korea, Republic of |
Mexico |
Taiwan |
Turkey |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |