Overview

Clarithromycin,Lenalidomide and Dexamethasone for Relapsed/Refractory Myeloma

Status:
Withdrawn
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
Summary
This phase II study investigating the efficacy and safety of a combination of biaxin,lenalidomide and dexamethasone in subjects with relapsed/refractory MM.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Collaborator:
China Food and Drug Administration
Treatments:
BB 1101
Clarithromycin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Thalidomide
Criteria
Inclusion Criteria:

- Patient has a previous diagnosis of multiple myeloma

- Patient requires retreatment for multiple myeloma

- Subject has measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >10
mg/dL involved serum free light chain (either kappa or lambda) provided that the serum
free light chain ratio is abnormal, >0.2 g/24 hrs urinary M-protein excretion, and/or
measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either
CT scanning or MRI

- Subject has a Karnofsky performance status ≥60% (>50% if due to bony involvement of
myeloma (see Appendix IV)

- Subject has a life expectancy ≥ 3 months

- Subjects must meet the following laboratory parameters:

Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L) Hemoglobin ≥ 7 g/dL Platelet
count ≥ 75,000/mm3 (30 x 109/L if extensive bone marrow infiltration) Serum SGOT/AST <3.0 x
upper limits of normal (ULN) Serum SGPT/ALT <3.0 x upper limits of normal (ULN) Serum total
bilirubin <2.0 mg/dL (34 µmol/L) Creatinine clearance ≥ 30 cc/min

Exclusion Criteria:

- Subject has immeasurable MM (no measurable monoclonal protein, free light chains in
blood or urine, or measureable plasmacytoma on radiologic scanning)

- Subject has a prior history of other malignancies unless disease-free for ≥ 5 years,
except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the
cervix or breast, or localized prostate cancer with Gleason score < 7 with stable
prostate specific antigen (PSA) levels

- Subject has had myocardial infarction within 6 months prior to enrollment, or NYHA
(New York Hospital Association) Class III or IV heart failure (see Appendix VI),
Ejection Fraction < 35%, uncontrolled angina, severe uncontrolled ventricular
arrhythmias, electrocardiographic evidence of acute ischemia or active conduction
system abnormalities

- Female subject who is pregnant or lactating

- Subject has known HIV infection

- Subject has known active hepatitis B or hepatitis C infection

- Subject has active viral or bacterial infections or any coexisting medical problem
that would significantly increase the risks of this treatment program

- Subject is unable to reliably take oral medications

- Subject has known hypersensitivity to dexamethasone,cyclophosphamide,paclitaxel

- Subject has a history of thromboembolic event within the past 4 weeks prior to
enrollment

- Subject has any clinically significant medical or psychiatric disease or condition
that, in the investigator's opinion, may interfere with protocol adherence or a
subject's ability to give informed consent