Phase I/II trial of Lenalidomide plus Bortezomib combined with Dexamethasone in elderly patients in 1st relapse or primary refractory after first line therapy for Multiple Myeloma - HOVON 86 MM

Phase 1

• Conditions: multiple myeloma; MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2007-002533-37-BE
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-07
• Last Update Posted: 27 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

- Multiple Myeloma Salmon/Durie stage II/III A+B
- Primary refractory to or first relapse after previous objective response (PR, VGPR, CR) on standard first-line treatment
- Age 60 – 85 years inclusive
- Not a candidate for high-dose therapy
-Measurable disease, i.e., serum M-component (>10 g/l), or urinary light-chain excretion (>200mg/24h),or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/l or proven plasmacytoma by biopsy
- Able and/or willing to use adequate contraceptives (especially male patients)
- Written 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Prior therapy with Bortezomib or Lenalidomide
-History of allergic reaction attributable to compounds containing boron or mannitol.
-Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3.
-AL amyloidosis
- Uncontrolled or severe cardiovascular disease:
New York Heart Association (NYHA) Class III or IV heart failure
Myocardial infarction within the last 6 months of study entry
Reduced left ventricular function with an ejection fraction < 50% as measured by
MUGA scan or echocardiogram (another method for measuring cardiac function is
acceptable)
Unstable angina
Unstable cardiac arrhythmias
Clinically significant pericardial disease

- Impaired hepatic or renal function as defined by:
ALT and/or AST > 3 x normal value
Bilirubin > 3 x normal value
Serum creatinin > 3 x normal value (after adequate hydration)
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled
diabetes, infection, hypertension, etc.)
- Known HIV positivity
- History of active malignancy during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma

Study & Design

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