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

Phase III trial in patients with multiple myeloma to optimize bortezomib based induction (bortezomib, Adriamycin®, dexamethasone [PAd] vs. bortezomib, cyclophosphamide, dexamethasone [VCD]) prior to high dose therapy and autologous stem cell transplantation followed by lenalidomide based consolidation and maintenance therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN05745813

Enrollment

504

Registered

2009-11-11

Start date

2010-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma Cancer Multiple myeloma

Interventions

1. Patients are randomised into four treatment arms (A1, A2, B1, B2) 2. Patients included in arms A1/B1 are treated with 3 cycles PAd (bortezomib 1.3 mg/m^2 intravenous [iv] on days 1, 4, 8 and 11, do

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of multiple myeloma requiring systemic therapy 2. Measurable disease 3. Age 18 - 70 years inclusive, either sex

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Response to treatment (very good partial remission or better) after induction therapy 2. Progression free survival (i.e., time from randomisation to progression or death from any cause, whichever occurs first) 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

Measure	Time frame
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. 2. Response to be measured after induction, after transplantation, after consolidation and during maintenance 2.1. Partial remission (PR) 2.2. Very good partial remission (VGPR) 2.3. Complete remission (CR) 2.4. Molecular complete remission (mCR) 3. Toxicity ([serious] adverse events CTC grade 3 and grade 4, CTC-AE v4.0) related to induction, consolidation and maintenance treatment 4. Progression free survival from HDT (i.e., time from last HDT treatment to progression or death from any cause whichever occurs first)	—

Measure

Time frame

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. 2. Response to be measured after induction, after transplantation, after consolidation and during maintenance 2.1. Partial remission (PR) 2.2. Very good partial remission (VGPR) 2.3. Complete remission (CR) 2.4. Molecular complete remission (mCR) 3. Toxicity ([serious] adverse events CTC grade 3 and grade 4, CTC-AE v4.0) related to induction, consolidation and maintenance treatment 4. Progression free survival from HDT (i.e., time from last HDT treatment to progression or death from any cause whichever occurs first)

—

Countries

France, Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026