InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 7 February 2024

ALLG MM16: This phase II trial is assessing carfilzomib (an anti-cancer drug) in patients with Multiple Myeloma who suffer from renal damagePhase II study assessing the effect of carfilzomib treatment on early free light chain kinetics in myeloma patients with renal impairmen

Clinical summary

Summary

The efficacy of proteasome inhibitors (bortezomib, carfilzomib) in reversing or ameliorating renal impairment in myeloma patients has been demonstrated. The response to myeloma therapy can often be better gauged by the reduction in serum free light chains which have a shorter half-life of 3 to 5 hours, as compared with the full immunoglobulin paraprotein. The initial, very early impact on the level of free light chains is therefore likely to be critical in the effectiveness of carfilzomib in reversing renal failure. We aim to assess the effect of carfilzomib therapy on serum free light chains at very early time-points (24 and 48 hours after the day 2 dose and 24 hours after day 9 dose) following dose administration, with the aim of assessing the value of these measurements as a marker of efficacy and, in future trials, the basis on which to modify treatment regime to maximise the improvement in renal function.

Conditions

This trial is treating patients with Multiple Myeloma.

Cancer

Blood Cancers Haematological

Age

People18 - 75

Phase

II

Trial Acronym

ALLG MM16

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Australasian Leukaemia and Lymphoma Group (ALLG)

Scientific Title

Phase II study assessing the effect of carfilzomib treatment on early free light chain kinetics in myeloma patients with renal impairmen

Eligibility

Inclusion

All of the following criteria must be satisfied for enrolment in the study.

Male and Female patients, >=18 years of age
Patients with newly diagnosed MM (diagnosis of MM as per IMWG –21)
Or
Multiple myeloma with relapsing or progressing disease at study entry,
With either
Measurable M-component in serum or urine,
In patients with no detectable M-component, an abnormal FLC ratio on the Serum FLC assay
For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) >= 750 mg^dL (0.75 g^dL).

Patients with acute renal injury as the cause of reduced renal function, with creatinine clearance 15-40 ml^min at screening (calculated by the CKD-EPI and MDRD formulae)

Difference between involved and uninvolved free light chain >=300 mg^L

Adequate liver function (total bilirubin < 1.5 ULN, ALT < 2.5x ULN)

Absolute neutrophil count >= 1.0 x 109^L within one week of starting therapy.

Platelet count >= 50 x 109^L (>= 30 x 109^L if myeloma involvement in the marrow is greater than 50%) within one week of starting therapy, patients should not have received platelet transfusions within one week of the screening platelet count

Hb >= 80g^L, red cell transfusions as per institutional protocol are allowed

Subject must have LVEF >= 40%, determined by 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.

Has provided written informed consent

Males capable of parenting a child and females of childbearing potential must be using a medically acceptable and adequate method of contraception while undergoing protocol treatment and for 12 weeks after the last treatment

Exclusion

Presence of any of the following criteria will exclude the subject from enrolment in the study.

Patients who have had myocardial infarction within 6 months prior to enrolment, or NYHA (New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities at any time.

Other uncontrolled intercurrent illness including, but not limited to, severe active infection, or psychiatric illness/social situations that would limit compliance with study requirements

Evidence of infection, dehydration or hypercalcaemia as the cause of acute kidney injury that has not been corrected.

Patients on dialysis at Screening.

Patients with known amyloidosis.

Patients with myelodysplastic syndrome.

Known history of allergy to Captisol (a cyclodextrin derivative used to solubilise carfilzomib)

Patients with contraindication to dexamethasone.

Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment.

Women who are pregnant or lactating. Females of child-bearing potential must have a negative urine pregnancy test at Screening.

Known Hepatitis B, Hepatitis C, HIV infection, other immunosuppressive therapy including dexamethasone or autoimmune disease

Prior diagnosis of cancer that was:
more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10%.
within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix.

Participation in other therapeutic studies in the last 60 days except for studies with a non-medical intervention. Documented evidence of receiving placebo will be required.

Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.