Multiple Myeloma Light Chain Induced Renal InsufficiencyPhase 2NCT00902915
Lenalidomide and Dexamethasone for Treatment of Patients With Acute Myeloma (Light Chain)-Induced Renal Failure
A Phase 2 study testing lenalidomide plus dexamethasone in people with Multiple Myeloma Light Chain Induced Renal Insufficiency, run by Austrian Forum Against Cancer at 5 sites in 2 countries.
Trial summary
The purpose of this study is to determine efficacy of lenalidomide and dexamethasone in the treatment of patients with acute Myeloma (light chain)-induced renal failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma Light Chain Induced Renal Insufficiency
- What is being tested?
- lenalidomide plus dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesin 2 countries
- Study dates
- May 2009to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign an informed consent form.
- Age at least 18 years at the time of signing the informed consent form.
- MM (all stages) with acute light chain induced renal impairment
- Patients with previously unknown MM and acute light chain induced renal failure (GFR<50ml/min and serum creatinine minimum 2.0 mg/dL) and with further workup revealing light chain induced renal injury with MM as underlying cause.
- Patients with previously established MM and normal renal function (GFR ≥60ml/min and serum creatinine ≤1.2mg/dl) with progressive disease and acute (within 6 weeks) light chain induced renal failure (GFR<50ml/min and creatinine ≥ 2.0 mg/dL).
- Disease progression will be documented by one or more of the following criteria:
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- Increase in serum paraprotein by >25%, or increase of 50% of 24 hour urine paraprotein excretion
- Hypercalcemia
- Progression of bone lesions
- Decrease in Hb>2g/dl within 4 weeks (not induced by cytotoxic drugs)
- Increase in bone marrow plasma cell infiltration by > 25%
- All previous medical anti-myeloma therapy (excluding corticosteroids) must have been discontinued at least 3 weeks prior to treatment in this study.
- Able to adhere to the study visit schedule and other protocol requirements.
- Measurable serum or urine paraprotein
- Laboratory test results within these ranges:
- Glomerular filtration rate < 50ml/min
- Serum creatinine ≥ 2.0mg/dL
- Absolute leukocyte count ≥ 1.5 x 10G/L
- Platelet count minimum 75 x 10G/L if bone marrow plasma cell infiltration (BMPC) is ≥50% or minimum 30 x 10G/L if BMPC infiltration is <50%.
- Total bilirubin minimum 1.5 mg/dL
- AST (SGOT) and ALT (SGPT) not more than 2,5 x ULN
- Females of childbearing potential (FCBP) must:
- Understand that the study medication could have an expected teratogenic risk
- Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception: Implant, Levonorgestrel-releasing intrauterine system (IUS, Medroxyprogesterone acetate depot), Tubal sterilization, Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
- Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
- Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
- Male subjects must:
- Agree to use condoms throughout study drug therapy, during any dose interruption and for 28 days after cessation of study therapy if their partner is of childbearing potential and has no contraception.
- Agree not to donate semen during study drug therapy and for 28 days after end of study drug therapy.
- All subjects must agree not to share study medication with another person and to return all unused study drug to the investigator
- Disease free of prior malignancies for minimum of 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
- Agree to take low molecular weight heparin as prophylactic anticoagulation.
Who cannot join
- Acute renal failure due to other causes than light-chain induced nephropathy such as NSAIRS, antibiotics, or other nephrotoxic drugs, or others.
- Acute renal failure due to hypercalcemia only, without excretion of nephrotoxic light chains.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Any prior use of lenalidomide
- Any anti-myeloma therapy within 3 weeks before day 1 of first cycle, with the exception of dexamethasone 40mg (maximum dose 160mg) or corticosteroid equivalent.
- Any other experimental drug or therapy within 3 weeks of baseline
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- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Known positive for HIV or infectious hepatitis, type A, B or C or evidence of any severe active or chronic infection.
- Clinical significant heart disease (NYHA status>2)
- Pregnant or breast feeding females
- Anamnesis of thromboembolic complications, such as stroke, myocardial infarction and pulmonary embolism
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Austria3 sites
LKH Salzburg, 3rd Med. Dept.
Salzburg, 5020
Austrian Forum Against Cancer; 1st Med. Dept., Center for Hematology and Oncology, Wilhelminenspital, Montleartstrasse 37
Vienna, 1160
Clinic Wels-Grieskirchen, 4th Internal Dept.
Wels, 4600
Czechia2 sites
Faculty Hospital Brno and Faculty of Medicine MU
Brno, 62500
Charles University Prague
Prague, 12821
About this study
The purpose of this study is to determine efficacy of lenalidomide and dexamethasone in the treatment of patients with acute Myeloma (light chain)-induced renal failure.
- Being tested
- lenalidomide plus dexamethasone
- Keywords
- multiple myeloma renal insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomide plus dexamethasoneDrug
peroral application; lenalidomide dosage according to severity grade of renal failure.
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide - Dexamethasone | Experimental | Not described Receives: Drug: lenalidomide plus dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the response rate (CR, VGPR, PR, MR, SD, and PD) To determine the renal response rate To determine the relation between category of myeloma response and improvement in GFR To determine the proportion of patients spared hemodialysis
Secondary outcomes (1)
Progression Free Survival, Event Free Survival, Overall Survival; Toxicity, evaluated according to the NCCN toxicity scale (type, frequency, severity, and relationship of adverse events to study treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma Light Chain Induced Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Austrian Forum Against Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902915
- Sponsor's protocol ID
- LD
- Status last verified
- Nov 2013
- First submitted
- 14 May 2009
- Last updated
- 25 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenalidomide and Dexamethasone for Treatment of Patients With Acute Myeloma (Light Chain)-Induced Renal Failure
- ClinicalTrials.gov ID
- NCT00902915
- Acronym / sponsor ID
- LD
- Keywords
- multiple myeloma renal insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Austrian Forum Against CancerUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine efficacy of lenalidomide and dexamethasone in the treatment of patients with acute Myeloma (light chain)-induced renal failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide - Dexamethasone | Experimental | Drug: lenalidomide plus dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Understand and voluntarily sign an informed consent form.
- Age at least 18 years at the time of signing the informed consent form.
- MM (all stages) with acute light chain induced renal impairment
- Patients with previously unknown MM and acute light chain induced renal failure (GFR<50ml/min and serum creatinine minimum 2.0 mg/dL) and with further workup revealing light chain induced renal injury with MM as underlying cause.
- Patients with previously established MM and normal renal function (GFR ≥60ml/min and serum creatinine ≤1.2mg/dl) with progressive disease and acute (within 6 weeks) light chain induced renal failure (GFR<50ml/min and creatinine ≥ 2.0 mg/dL).
Key exclusion criteria (12 listed)
- Acute renal failure due to other causes than light-chain induced nephropathy such as NSAIRS, antibiotics, or other nephrotoxic drugs, or others.
- Acute renal failure due to hypercalcemia only, without excretion of nephrotoxic light chains.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Any prior use of lenalidomide
- Any anti-myeloma therapy within 3 weeks before day 1 of first cycle, with the exception of dexamethasone 40mg (maximum dose 160mg) or corticosteroid equivalent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lenalidomide plus dexamethasoneperoral application; lenalidomide dosage according to severity grade of renal failure. | Drug | Lenalidomide - Dexamethasone |
Primary outcome
To determine the response rate (CR, VGPR, PR, MR, SD, and PD) To determine the renal response rate To determine the relation between category of myeloma response and improvement in GFR To determine the proportion of patients spared hemodialysis
1 secondary outcome
Progression Free Survival, Event Free Survival, Overall Survival; Toxicity, evaluated according to the NCCN toxicity scale (type, frequency, severity, and relationship of adverse events to study treatment).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lenalidomide plus dexamethasone in people with Multiple Myeloma Light Chain Induced Renal Insufficiency, run by Austrian Forum Against Cancer at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the response rate (CR, VGPR, PR, MR, SD, and PD) To determine the renal response rate To determine the relation between category of myeloma response and improvement in GFR To determine the proportion of patients spared hemodialysis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.