Know Cancer

forgot password

Randomised, Controlled, Open-labelled, Multi-centre Comparison of Thalidomide Versus High-dose Dexamethasone for the Treatment of Relapsed Refractory Multiple Myeloma

Phase 3
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

Randomised, Controlled, Open-labelled, Multi-centre Comparison of Thalidomide Versus High-dose Dexamethasone for the Treatment of Relapsed Refractory Multiple Myeloma

Inclusion Criteria:

- Male or female patients, aged ≥ 18 years at the time of signing the informed consent

- Patients who have been previously diagnosed with MM who have received between 1 & 3
prior lines of treatment for their disease, and who require therapy because of
disease progression

- Secretory MM with measurable levels of monoclonal protein in serum (> 10 g/L of IgG
M-protein or > 5 g/L of IgA M-protein) or urine (≥ 200 mg/ 24hours); Patient with the
following rare subclasses of the immunoglobulin: IgD, IgE, IgM can be included in the
study if the level of monoclonal protein in serum is > 5g/L or ≥ 200 mg/24hours in
urine. As IgM immunoglobulin isotype can be related to Waldenstrom's
macroglobulinemia, it is important to distinguish and not include in the study
patients with Waldenstrom's macroglobulinemia.

- ECOG performance status of 0, 1, or 2

- Life expectancy >3months

- Able to adhere to the study visit schedule & other protocol requirements

- Women of child-bearing potential must agree to use 2 methods of contraception for at
least 4weeks before starting the therapy, during the Treatment Period, & for 4 weeks
after the last dose

- Males must agree to use barrier contraception (latex condoms) when engaging in
reproductive activity during the Treatment Period & for 4 weeks after the last dose

- Written, informed consent

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the patient from signing the Informed Consent Form

- Pregnant or lactating women. A serum β-hCG pregnancy test must be performed at the
Screening visit for female patients of child-bearing potential. If the test is
positive, the patient must be excluded from the study. Confirmation that the patient
is not pregnant must be established by a negative serum or urinary pregnancy test
with the result obtained 1day prior to the Baseline visit (or the day of the visit if
results are available before drug delivery). A pregnancy test is not required for
naturally post-menopausal women (who have not had menses at any time in the preceding
24 consecutive months) or surgically sterilized women (hysterectomy, bilateral
ovariectomy, bilateral salpingectomy)

- Non-secretory MM

- Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) <500
cells/mm3 (0.5 x 109/L); Platelet count <30,000/mm3 (30.0 x 109L) without transfusion
support within 7 days before the test; Serum creatinine >3.0mg/dL (265μmol/L); Serum
aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) >3.0 x upper
limit of normal (ULN); Serum total bilirubin >2.0mg/dL (34μmol/L)

- Any condition, including the presence of laboratory abnormalities, which places the
patient at unacceptable risk if s/he were to participate in the study, or which
confounds the ability to interpret data from the study

- Severe cardiac dysfunction (according to the New York Heart Association [NYHA]
classification III-IV)

- Severe bradycardia (<50bpm)

- Peripheral neuropathy ≥Grade 2 in severity (according to the NCI CTC Version 3.0)

- Prior history of malignancy (except for basal cell or squamous cell carcinoma of the
skin or carcinoma in situ of the cervix or breast) unless the patient has been free
of disease for ≥5years

- Patient received any chemotherapy, corticosteroids (> 10 mg/day prednisone or
equivalent as a continuous dose) within 4 weeks before randomization

- Previously treated with thalidomide or thalidomide derivatives

- Patients refractory to high-dose dexamethasone (defined as experiencing less than a
PR to dexamethasone, or PD within 6months after discontinuing dexamethasone, or
discontinued dexamethasone because of ≥Grade 3 dexamethasone-related toxicity.
Previous high-dose dexamethasone therapy is defined as >500mg dexamethasone or
equivalent over a 10week period, whether administered alone or as part of the VAD

- Contraindications for high-dose dexamethasone

- Active or chronic gastrointestinal ulcers, active viral infections (herpes,
varicella, HIV, hepatitis B, hepatitis C), glaucoma, uncontrolled hypertension, or
diabetes mellitus, unless well controlled & under strict supervision during
dexamethasone treatment

- Patient enrolled in another clinical trial or who have participated in another trial
with the last 4weeks before randomization

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The evaluation of Independent Review Committee-documented time to progression (TTP).

Outcome Time Frame:

>160 "IRC confirmed" disease progression in the Dexamethasone or Thalidomide 400 mg/day arms

Safety Issue:


Principal Investigator

Martin Kropff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitatsklinikum Munster


European Union: European Medicines Agency

Study ID:

THA PH INT 2005 CL001



Start Date:

February 2006

Completion Date:

January 2009

Related Keywords:

  • Multiple Myeloma
  • Relapsed Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell