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Multiple MyelomaPhase 1/2MM_LEN_DEX_CYNCT01019174

Lenalidomide/Low-dose Dexamethasone in Combination With Continuous Oral Cyclophosphamide Compared to Lenalidomide/Low-dose Dexamethasone Combined With Single Cyclophosphamide Doses IV in Patients With Relapsed/Refractory Multiple Myeloma

A Phase 1/2 study testing Cyclophosphamide in people with Multiple Myeloma, run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the efficacy and tolerability of LEN/low-dose DEX and continuous low-dose CY administered orally compared to LEN in combination with low-dose DEX and single CY doses IV in patients with relapsed MM. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesGermany
Study dates
Nov 2009to Dec 2013
Phase
Phase 1/2
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.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Previously diagnosed with multiple myeloma based on standard criteria and requires therapy for primary refractory disease or 1st - 3rd relapse because of progressive disease (PD), defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytoma, or hypercalcemia (serum calcium > 11.3 mg/dL), or clinical relapse from CR.
  • At least one measurable disease manifestation defined as follows:
  • For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, > 1g/dL IgG M-protein or > 0.5 g/dL IgA) and, where applicable, urine light-chain excretion of ≥ 200 mg/24 h.
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  • For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or a quantifiable plasma cell infiltration of the bone marrow as determined by bone marrow biopsy.
  • ECOG performance status equal to or less than 2 at time of randomization/registration (see Appendix I).
  • Laboratory test results within these ranges within 1 week prior to randomization/registration:
  • Absolute neutrophil count ≥ 1.5 x 109/L without the use of colony stimulating factors within 14 days before the laboratory test.
  • Platelet count ≥ 75 x 109/L without transfusion support within 14 days before the laboratory test.
  • Hemoglobin ≥ 7.5 g/dL (regardless of transfusion support or prior medication with erythropoietin).
  • Calculated creatinine clearance ≥ 50 mL/minute.
  • Total bilirubin equal to or less than 1.5 mg/dL.
  • AST (SGOT) and ALT (SGPT) equal to or less than 2,5 x ULN.
  • Corrected serum calcium < 14 mg/dL (< 3.5 mmol/L).
  • Female subjects of childbearing potential must:
  • Understand that the study medication could have a potential 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 amenorrhoea. 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 sterilisation
  • 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)
  • Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception
  • Prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection
  • Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days from 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 one week 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 one week after end of study drug therapy.
  • All subjects must
  • Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
  • 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 ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
  • Able and willing to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
  • Life-expectancy > 3 months.

Who cannot join

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Females, who are pregnant, calculate to get pregnant or are breast feeding (Lactating females must agree not to breast feed while taking lenalidomide).
  • Any condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Patient currently is enrolled in another clinical research study or has been enrolled in such a study within 4 weeks before randomization/registration and/or is receiving an investigational agent for any reason or has received such an agent within 4 weeks before randomization/registration.
  • Known hypersensitivity to thalidomide, dexamethasone, or cyclophosphamide or similar drugs.
  • Any prior use of lenalidomide.
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  • Concurrent use of other anti-cancer agents or treatments.
  • Known positive for HIV or infectious hepatitis, type A, B or C.
  • Any other chemotherapy or high-dose dexamethasone within 4 weeks before randomization/registration.
  • Immunotherapy or antibody therapy within 8 weeks before randomization/registration.
  • Major surgery within 4 weeks before randomization/registration.
  • Myocardial infarction within 6 months before randomization/registration, New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Cardiac amyloidosis.
  • Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.
  • Any systemic infection requiring treatment.
  • Cystitis.
  • Disturbance of urinary flow.
  • Unable or unwilling to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • University Clinic München-Großhadern

    München, 81377

  • University of Münster, Department of Hematology/Oncology

    Münster, 48129

  • Tübingen University, Department of Hematology/Oncology/Immunology

    Tübingen, 72076

  • University Clinic Ulm, Department Internal Medicine

    Ulm, 89081

Other trials in Germany

About this study

Official title: An Open, Randomized Clinical Phase I/II Trial to Investigate Maximum Tolerated Dose, Efficacy, and Safety of Lenalidomide/Low-dose Dexamethasone in Combination With Continuous Oral Cyclophosphamide Compared to Lenalidomide/Low-dose Dexamethasone Combined With Single Cyclophosphamide Doses IV in Patients With Relapsed/Refractory Multiple Myeloma

The purpose of this study is to investigate the efficacy and tolerability of LEN/low-dose DEX and continuous low-dose CY administered orally compared to LEN in combination with low-dose DEX and single CY doses IV in patients with relapsed MM.

Read the detailed description

This is an open, randomized, multicenter, phase I/II study with a parallel group design investigating an intravenous and an oral CY dosing schedule in combination with LEN and low-dose DEX in patients with refractory or relapsed MM. In phase I MTD of CY will be determined using a common dose escalation scheme with 3 to 6 patients per dose level. In phase II, efficacy and safety of the treatment regimens at the MTD will be investigated in 20 patients.

Being tested
Cyclophosphamide
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclophosphamideDrug

    Also called Revlimid, Endoxan

    comparison of lenalidomide/low-dose dexamethasone in combination with continuous oral cyclophosphamide to lenalidomide/low-dose dexamethasone combined with single cyclophosphamide doses intravenous

  • CyclophosphamideDrug

    Also called Revlimid, Endoxan

    comparison of lenalidomide/low-dose dexamethasone in combination with continuous oral cyclophosphamide to lenalidomide/low-dose dexamethasone combined with single cyclophosphamide doses intravenous

Study groups in NCT01019174
Study groupRoleWhat they receive
oral applicationActive comparatororal application Cyclophosphamide
Receives: Drug: Cyclophosphamide
intravenous applicationActive comparatorintravenous application Cyclophosphamide
Receives: Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the maximum tolerated dose (MTD) of CY (PO and IV) in combination with LEN/low-dose DEX

    Measured: 3 years

  2. To investigate the best objective response (EBMT criteria) to both treatment regimens

    Measured: 3 years

Secondary outcomes (2)

  1. To investigate safety and tolerability of both treatment regimens

    Measured: 3 years

  2. To investigate other efficacy parameters of both treatment regimens

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01019174
Sponsor's protocol ID
RV-MM-DSMM-0279
Other IDs
GMIHO-005/2008
Acronym
MM_LEN_DEX_CY
Status last verified
Jul 2014
First submitted
24 Nov 2009
Last updated
20 Feb 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cyclophosphamide in people with Multiple Myeloma, run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 4 sites in Germany.

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 37 inclusion and 18 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: finished, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 maximum tolerated dose (MTD) of CY (PO and IV) in combination with LEN/low-dose DEX (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01019174.

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 20 Feb 2017.

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MM_LEN_DEX_CY Clinical Trial NCT01019174 | AzTrials