The GMMG-HD5 trial: bortezomib-based induction prior to high dose therapy and autologous stem cell transplantation followed by lenalidomide-based consolidation and maintenance therapy in patients with multiple myeloma
Completed
- Conditions
- Multiple myelomaCancer
- Registration Number
- ISRCTN05745813
- Lead Sponsor
- Heidelberg University (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 504
Inclusion Criteria
1. Confirmed diagnosis of multiple myeloma requiring systemic therapy
2. Measurable disease
3. Age 18 - 70 years inclusive, either sex
Exclusion Criteria
1. Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression
2. Severe cardiac dysfunction
3. Significant hepatic dysfunction
4. Patients known to be human immunodeficiency virus (HIV)-positive
5. Patients with active, uncontrolled infections
6. Patients with peripheral neuropathy or neuropathic pain, Common Toxicity Criteria (CTC) grade 2 or higher
7. Patients with a history of active malignancy during the past 5 years
8. Systemic AL amyloidosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Response to treatment (very good partial remission or better) after induction therapy <br>2. Progression free survival (i.e., time from randomisation to progression or death from any cause, whichever occurs first)<br>Patients will be investigated for progression after every treatment phase (induction, HDT, consolidation) and then every 3 months in maintenance treatment and follow up
- Secondary Outcome Measures
Name Time Method 1. Overall survival defined as time from randomisation to death from any cause. Patients still alive or lost to follow up are censored at the date they were last known to be alive.<br>2. Response to be measured after induction, after transplantation, after consolidation and during maintenance <br>2.1. Partial remission (PR)<br>2.2. Very good partial remission (VGPR) <br>2.3. Complete remission (CR) <br>2.4. Molecular complete remission (mCR)<br>3. Toxicity ([serious] adverse events CTC grade 3 and grade 4, CTC-AE v4.0) related to induction, consolidation and maintenance treatment <br>4. Progression free survival from HDT (i.e., time from last HDT treatment to progression or death from any cause whichever occurs first)