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Randomised Comparisons, in Myeloma Patients of All Ages, of Thalidomide, Lenalidomide and Bortezomib Induction Combinations, and of Lenalidomide and Combination Lenalidomide Vorinostat as Maintenance


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Randomised Comparisons, in Myeloma Patients of All Ages, of Thalidomide, Lenalidomide and Bortezomib Induction Combinations, and of Lenalidomide and Combination Lenalidomide Vorinostat as Maintenance


The last ten years has seen the introduction of a number of effective new anti-myeloma
agents into the clinical arena. These agents have been shown to be highly effective in the
relapse setting and now are being introduced as treatment earlier in the disease course.

This study aims to address in the randomised setting some of the key questions concerning
the use of thalidomide, bortezomib, lenalidomide and vorinostat in the initial treatment of
multiple myeloma patients.

Newly diagnosed patients of all ages with symptomatic myeloma requiring treatment are
eligible.

For initial treatment, thalidomide in combination with cyclophosphamide and dexamethasone,
the UK gold standard, will be compared with the newer combination of lenalidomide,
cyclophosphamide and dexamethasone.

For patients with a sub-optimal response to initial therapy, the response to the proteasome
inhibitor bortezomib will be assessed, as previous studies have demonstrated that it is able
to induce responses and improve progression-free and overall survival in patients resistant
to standard chemotherapy. Patients young and fit enough to tolerate an autologous transplant
will then proceed to high dose melphalan with peripheral blood stem cell rescue and then on
to maintenance randomisation. Older or less fit patients will go directly to a maintenance
randomisation.

The value of lenalidomide and lenalidomide combined with vorinostat maintenance will then be
assessed by randomising eligible patients to receive either lenalidomide, lenalidomide
combined with vorinostat maintenance therapy, or close observation.

The primary end points of the study are overall and progression-free survival (OS and PFS).
Secondary end points include response and toxicity.

A number of laboratory based studies will also be performed in order to determine patient
specific factors predicting overall and progression-free survival and response to treatment.


Inclusion Criteria:



- Aged 18 years or greater

- Newly diagnosed as having symptomatic multiple myeloma or non-secretory multiple
myeloma

- Provide written informed consent

- Women of childbearing potential and male patients whose partner is a woman of child
bearing potential must be prepared to use contraception in accordance with (and
consent to) the Celgene-approved process for thalidomide and lenalidomide Risk
Management and Pregnancy Prevention, or commit to absolute and continuous abstinence

- Women of child bearing potential must have a negative pregnancy test performed by a
healthcare professional in accordance with the Celgene-approved process for
thalidomide and lenalidomide Risk Management and Pregnancy Prevention

Exclusion Criteria:

- Asymptomatic myeloma

- Solitary plasmacytoma of bone. (Patients with previous solitary plasmacytoma now
progressed to symptomatic or non-secretory myeloma are eligible)

- Extramedullary plasmacytoma (without evidence of myeloma)

- Previous (<5 years since diagnosis) or concurrent active malignancies, except
surgically-removed basal or squamous cell carcinoma of the skin, treated carcinoma in
situ of the breast or cervix, or incidental histologic finding of prostate cancer
(TMN stage of T1a or 1b). Patients with remote histories (>5 years) of other cured
malignancies may be entered.

- Documented diagnosis of Myelodysplastic Syndrome (MDS) that meets International
Prognostic Scoring System (IPSS) criteria for high-risk disease

- Previous treatment for myeloma, except the following:

local radiotherapy to relieve bone pain or spinal cord compression or prior bisphosphonate
treatment or corticosteroids within the last 3 months

- Known history of allergy contributable to compounds containing boron or mannitol

- Grade 2 or greater (NCI criteria) peripheral neuropathy

- Caution is advised in patients with a past history of ischaemic heart disease,
pericardial disease, acute diffuse infiltrative pulmonary disease or psychiatric
disorders, evidence of impaired marrow function or elevated liver function tests, but
exclusion is essentially to be at the discretion of the treating clinician

- Acute renal failure (unresponsive to up to 72 hours of rehydration, characterised by
creatinine >500┬Ámol/L or urine output <400 mL/day or requirement for dialysis)

- Lactating or breastfeeding

Type of Study:

Interventional

Study Design:

N/A

Outcome Measure:

Overall survival

Outcome Description:

Overall survial for induction chemotherapy comparisons is defined as the time from initial randomisation to the trial to death from any cause or last follow-up. Overall survival for maintenance therapy comparisons is defined from the time of maintenance randomisation.

Safety Issue:

Yes

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

EudraCT number: 2009-010956-93

NCT ID:

NCT01554852

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • myeloma
  • lenalidomide
  • Revlimid
  • cyclophosphamide
  • dexamethasone
  • bortezomib
  • Velcade
  • vorinostat
  • Zolinza
  • stem cell
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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