Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma (dtZ)

IHH Healthcare

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: thalidomide; Drug: zoledronic acid; Drug: dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00263484

SQMM01(dtZ)

Details and patient eligibility

About

The purpose of this study is to determine whether lower than conventional doses of dexamethasone and thalidomide; and a higher dosing frequency of zoledronic acid are effective in the treatment of newly-diagnosed multiple myeloma.

Full description

Patients with newly-diagnosed multiple myeloma (MM) may be treated using monthly cycles of dexamethasone plus thalidomide (DT). Unfortunately, the use of conventional doses of DT is associated with significant treatment-related morbidity and mortality, which is comparable to that observed with conventional chemotherapy. Hence, for safety reasons, patients frequently receive lower than conventional doses of DT (i.e. dt), and potentially experience a poorer anti-MM effect. The highly-potent aminobisphosphonate, zoledronic acid (Z), has been shown in pre-clinical mouse models to exhibit an impressive anti-MM effect. It is therefore possible to combined dt with Z (i.e. dtZ) to enhance the efficacy of (lower dose) dt. In addition, the anti-tumor effect of dtZ may potentially be augmented by using Z at a higher (three-weekly) dosing frequency.

Enrollment: 56 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age at or above 21 years
• Clinical diagnosis of MM
• Active MM with measurable disease
• Signed written informed consent
• Signed consent for drug safety program for thalidomide

Exclusion criteria

• Patients with Monoclonal Gammopathy of Undetermined Significance (MGUS)
• Patients with Indolent MM (IMM), or Smouldering MM (SMM)
• Known hypersensitivity (including severe cutaneous reactions) to d, t or Z
• Fulminant sepsis
• Females in the reproductive age group who refuse contraception
• Pregnancy
• 24 hr urinary creatinine clearance time (CCT) <30 ml/min
• Previous renal transplantation
• Severe peripheral neuropathy
• Recurrent DVT or PE
• Severe arrhythmias and cardiac conduction disorders
• Liver dysfunction of active viral hepatitis
• Osteonecrosis of the jaws (ONJ)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

"dtZ" regimen, Initial therapy

Experimental group

Description:

To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma.

Treatment:

Drug: dexamethasone

Drug: zoledronic acid

Drug: thalidomide