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Phase II Study of Bortezomib Dexamethasone and High-dose Melphalan in Patients With Relapse After High-dose Melphalan With Autologous Stem Cell Support

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Phase II Study of Bortezomib Dexamethasone and High-dose Melphalan in Patients With Relapse After High-dose Melphalan With Autologous Stem Cell Support

Patients with multiple myeloma who have their first treatment demanding relapse after an
initial treatment with high-dose melphalan with autologous stem cell support and who have
more than 2.0 x 10^6 CD34+ stem cells pr kg bodyweight in the freezer can be included in the

After disease status with basic clinical biochemistry, M-protein in blood and urine, bone
marrow investigation including immunophenotyping and total skeletal x-ray the patients are
treated with three courses of standard bortezomib (1.3 mg/sqm Days 1,4,8,11) and
dexamethasone 20 mg days 1,2,4,5,8,9,11,12. Within 4 weeks the patients receive bortezomib
days -5 and -2, high-dose melphalan (200 mg/sqm) day -2, and subsequent at least 2.0 x 10^6
CD34+ stem cells pr kg body weight.

The first month after high-dose therapy the patients are followed closely for toxicity
according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI
CTCAE), Version 3.0.

The patients are evaluated for response according to EBMT criteria and for event (death or
progressive disease).

Inclusion Criteria:

- First relapse after ASCT

- Symptomatic myeloma

- More than 2,0 x 10^6 CD34+ stem cells / kg bodyweight in the freezer for stem cell

- Signed informed consent given prior to any study related activities have been

- Age > 18 years

Exclusion Criteria:

- Allogeneic transplantation scheduled as a part of the treatment

- Expected survival of less than one month.

- Performance status (WHO) > 3

- Neuropathy > Grade 3 (neurological symptoms interfering with ADL)

- Non-secreting myeloma

- Other concurrent disease making bortezomib treatment unsuitable

- Positive pregnancy test (only applicable for women with childbearing potential)

- Has known or suspected hypersensitivity or intolerance to melphalan, dexamethasone,
boron, mannitol, or heparin, if an indwelling catheter is used

- Uncontrolled or severe cardiovascular disease including myocardial infarction within
6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart
failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina,
clinically significant pericardial disease, or cardiac amyloidosis

- History of hypotension or has decreased blood pressure (sitting systolic blood
pressure [SBP] <= 100 mmHg and/or sitting diastolic blood pressure [DBP] <= 60 mmHg)

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study

- Have received an experimental drug or used an experimental medical device within 4
weeks prior to inclusion into the study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of the event free survival after first high-dose melphalan with stem cell support (ASCT) and a second ASCT combined with bortezomib treatment of first relapse

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Peter Gimsing, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Haematology, Rigshospitalet


Denmark: Danish Medicines Agency

Study ID:

NMSG 16-07



Start Date:

July 2007

Completion Date:

September 2010

Related Keywords:

  • Multiple Myeloma
  • high-dose melphalan
  • bortezomib
  • response
  • toxicity
  • relapse
  • Multiple Myeloma
  • Neoplasms, Plasma Cell