Phase 2
Completed N=26
A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma
Source: ClinicalTrials.gov NCT01698801 ↗Enrolled (actual)
26
Serious AEs
42.3%
Results posted
Dec 2014
Primary outcomePrimary: Overall Response Rate — 87.5 percentage of participants — p=<0.0001
Summary
To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
87.5 | <0.0001 sig |
| SECONDARY Time to Response |
1.97 | — |
| SECONDARY Duration of Response |
NA | — |
| SECONDARY Progression Free Survival (PFS) |
NA | — |
| SECONDARY Overall Survival (OS) |
17.71 | — |
| SECONDARY Number of Participants With Adverse Events |
26; 25; 25; 20; 18; 15 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 20 years at the time of signing the informed consent document
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
- Able to adhere to the study visit schedule and other protocol requirements
- Previously untreated, symptomatic multiple myeloma
- Have measurable disease by protein electrophoresis analyses
- At least 65 years of age or older or, if younger than 65 years of age, not candidates for hematopoietic stem cell transplantation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan
Exclusion Criteria
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Any condition that confounds the ability to interpret data from the study
- Previous treatment with anti-myeloma therapy
- Pregnant or lactating females
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) 3.0 × upper limit of normal
- Renal failure requiring hemodialysis or peritoneal dialysis
- Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years
- Subjects who are unable or unwilling to undergo antithrombotic therapy.
- Peripheral neuropathy of ≥ grade 2 severity.
- Uncontrolled systemic fungal, bacterial, or viral infection
- Known human immunodeficiency virus (HIV) positivity (subjects who are receiving antiretroviral therapy for HIV disease)
- Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. In case HBc antibody and/or HBs antibody is positive even if HBs antigen-negative, a Hepatitis B virus (HBV) DNA test should be performed and if positive the subject will be excluded.
- Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
- Ineligible for dexamethasone or dexamethasone is contraindicated.
Data sourced from ClinicalTrials.gov (NCT01698801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.