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Clinical Protocol Bortezomib Consolidation in Patients With Myeloma Following Treatment With High-dose Melphalan and Autologous Stem Cell Support. A Randomised NMSG Trial (15/05)


Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

Clinical Protocol Bortezomib Consolidation in Patients With Myeloma Following Treatment With High-dose Melphalan and Autologous Stem Cell Support. A Randomised NMSG Trial (15/05)


Rationale:

ASCT prolongs EFS and OS for myeloma patients < 65 years of age. During the period from ASCT
to progression most myeloma patients experience few symptoms and have a good quality of
life11. A further prolongation of EFS would be a big step forward in myeloma treatment.
Bortezomib is a new promising agent, which has shown clear anti-myeloma effect in heavily
pre-treated patients. After ASCT the tumour cell burden is low and it is the hypothesis of
this clinical trial that the unique mechanism of action of bortezomib may reduce the number
of tumour cells even further and by doing so prolong EFS.

Primary objective:

* Evaluate the effect on EFS (an event is defined as either progression or death of any
cause without preceding progression) of consolidation treatment with bortezomib after ASCT
compared to no consolidation

Secondary objectives:

- Overall survival from ASCT

- Overall survival from start of relapse treatment

- Time to need for relapse treatment

- Response rate in patients not in CR following ASCT

- Toxicity from consolidation treatment

- Quality of life

- Cost utility

- Planned subgroup analysis: comparison of primary and secondary endpoint in patients
receiving one vs. two high dose treatments


Inclusion Criteria:



- Symptomatic myeloma diagnosis according to criteria in attachment 3

- ASCT is performed or has been performed in the last five weeks (time limit two weeks
for patients randomised at 2nd transplantation) as a part of primary therapy

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

Exclusion Criteria:

- Prior exposure to bortezomib

- Allogeneic transplantation scheduled as a part of the primary treatment

- Neuropathy > Grade 2 (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 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:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the effect on EFS (an event is defined as either progression or death of any cause without preceding progression) of consolidation treatment with bortezomib after ASCT compared to no consolidation

Outcome Time Frame:

1 year after randomization of the last patient

Safety Issue:

Yes

Principal Investigator

Ulf-Henrik Mellqvist, Dr., PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NMSG

Authority:

Sweden: Medical Products Agency

Study ID:

NMSG 15/05

NCT ID:

NCT00417911

Start Date:

December 2005

Completion Date:

May 2010

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • autologous stem cell transplantation
  • high-dose melphalan
  • bortezomib
  • consolidation
  • event free survival
  • phase III
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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