Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse

Multiple Myeloma Clinical Trial

— AZABACHE  

Official title:

Assessment of the Antitumour Effect of Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse: Prospective Clinical Trial of the GEM/PETHEMA Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087008
• Other study ID #: AZABACHE: 2009-017440-13
• Status: Completed
• Phase: Phase 4
• Start date: April 2010
• Est. completion date: June 5, 2013

Study information

• Verified date: April 2020
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessment of the antitumour effect of zoledronic acid in patients with multiple myeloma and asymptomatic biochemical relapse

It´s proposed to investigate the use of Zoledronic acid as single therapy in patients with Multiple Myeloma in biochemical relapse. The following must be noted:

• Patients with no formal indication for chemotherapy treatment will be included, as patients with symptomatic myeloma who after responding show biochemical relapse are generally not treated. This allows for generating both a group of patients untreated, on no additional treatment and a treatment group on zoledronic acid.

• As these are relapsing symptomatic patients, their number is far higher than patients with quiescent Multiple Myeloma. This allows for expecting a good enrolment.

• There are few reliable data on symptom progression after biochemical relapse, though it is one of the new objectives occurring in almost all clinical trials on myeloma. In the VISTA study, it has been estimated that the median time to the new treatment is 5 months (combining progression-free time and time to the next treatment). This time is much shorter than the median quiescent myeloma progression-free survival, so a very long follow-up time will not be necessary in this patient group.

• The administration of this drug to these patients can help prevent skeleton-related complications in the future, the study of which will be a secondary objective of this study.

Description:

Zometa is administrated every 4 weeks at dose of 4 mg. The limit of administrations is 12. The first infusion is in the visit 2 and the last is in visit 13

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 5, 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients aged =18 years.

• Signed informed consent before performing any study procedure that is not the part of the regular medical care of the patients.

• Diagnosis of MM, with biochemical relapse after initial response with no symptoms resulting from the disease (CRAB), defined as a re-positivation of a previous immunofixation (two samples) or increase above 25% of serum or urine protein M.

• In the investigator's opinion, ability to meet all clinical trial requirements

Exclusion Criteria:

• Treatment with bisphosphonates (oral route and/or endovenous route) within 3 months prior to inclusion.

• Treatment with denosumab within three months prior to inclusion.

• Criteria of symptomatic disease or organic damage related to disease, defined as:

• Impaired renal function: serum creatinine >2 mg/dl or 173 mmol/l. Calcium increase: serum calcium =12 mg/dl within 28 days prior to inclusion.

• Anaemia: haemoglobin < 10 g/dl or 2 g/dl below normal ranges.

• Bone injury: new osteolytic lesions (from diagnosis) seen within 3 months prior to inclusion, current pathological fractures or increase of osteopenia (from diagnosis) in bone radiology series.

• Others: amyloidosis with current organic damage, recurrent bacterial infections (more than 2 events in 12 months), symptomatic hyperviscosity, presence of plasmacytomas.

• Patients with current and active dental disorders (dental, jaw infection, bone exposed in the mouth, jaw osteonecrosis).

• Patients developing jaw osteonecrosis or other serious adverse events due to treatment with any bisphosphonate .

• Significant liver disease:

• Bilirubin > 3 g/dl.

• ALT > 2.5 x the upper limit of normal

• AST > 2.5 x the upper limit of normal

• Patients who are currently in another clinical trial or receiving any investigational agent.

• Pregnancy or nursing.

• Parathyroid gland diseases.

• Previous malignancy with a high risk of death or bone disease: breast cancer, prostate cancer or lung cancer, even if on complete response.

• Active presence of neoplasms other than Multiple Myeloma

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• zoledronic acid
Zoledronic acid 4 mg every 4 weeks for a total of 12 treatments

Other:
• No treatment control
Patients doesn't receive treatment

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias I Pujol	Badalona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d'Hebrón	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Jose María Morales Meseguer	Murcia
Spain	Hospital Central de Asturias	Oviedo
Spain	Hospital Son Llàtzer	Palma de Mallorca
Spain	Hospital Universitario Son Dureta	Palma de Mallorca
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario de Canarias	Tenerife
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario Dr. Peset.	Valencia
Spain	Hospital Universitario La Fe	Valencia
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
PETHEMA Foundation	Dynamic Solutions, Novartis

Country where clinical trial is conducted

Spain, 

References & Publications (3)

R. García-Sanz, A. Oriol, J. de la Rubia, L. Palomera, P. Ribas, MT. Hernández, MJ. Moreno, J. Bargay, A. Ramírez, AI. Teruel, MJ. Blanchard, M. Gironella, M. Granell, E. Abellá, MA Sampol, R. Martínez, JF San Miguel EVALUTION OF BENEFITS AND POTENTIAL AN

R. García-Sanz, A. Oriol, J. de la Rubia, L. Palomera, P. Ribas, MT. Hernández, MJ. Moreno, J. Bargay, A. Ramírez, AI. Teruel, MJ. Blanchard, M. Gironella, M. Granell, E. Abellá, MA Sampol, R. Martínez, JF San Miguel EVALUTION OF BENEFITS AND POTENTIAL AN

R. García-Sanz, A. Oriol, J. de la Rubia, L. Palomera, P. Ribas, MT. Hernández, MJ. Moreno, J. Bargay, A. Ramírez, AI. Teruel, MJ. Blanchard, M. Gironella, M. Granell, E. Abellá, MA Sampol, R. Martínez, JF San Miguel EVALUTION OF BENEFITS AND POTENTIAL AN

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to next need treatment	Time to the next treatment, considered as the time from the randomization date to the start of the next chemotherapy treatment for Multiple Mieloma or death for any cause	6 months
Secondary	Time to symptom relapse	Time to symptom relapse, considered as the time from randomization to symptom relapse	1 year
Secondary	disease progression	To describe the differences between patients treated with ZOL or not in terms of type of disease progression (bone and extra-bone).	2 years
Secondary	prognostic factors	To describe the prognostic factors in patients with MM and asymptomatic biochemical relapse	2 years
Secondary	antitumour effect of ZOL	To assess the antitumour effect of ZOL on other clinically significant parameters in MM, including tumour response to ZOL	1 year
Secondary	Overall survival		5 years

External Links

•   Novartis web page
•   Spnish Association of Haematology